Today my choice would be to risk prison and fines or suffer life threatening consequences, even death

I am sharing an experience that I had over 30 years ago. The entire experience was so traumatic that I have rarely talked about it. Brave women and men who voted down draconian anti-choice measures in #KansasVote gave me courage to share my story.

Some time into my marriage, when I realized I was pregnant, I was ecstatic. However, after only a month of finding it out, my husband lost his job and moved from Cincinnati to Minneapolis. It fell upon me to close down the house, pack up our stuff, send the movers and then fly to Minneapolis. Two days prior to flying out to Minneapolis, I went for a routine checkup and was informed by my gynecologist that the fetus had a very faint heartbeat and was not going to survive. He strongly advised me to not travel in that condition and in fact he suggested that I have an immediate D&C procedure and terminate the pregnancy. I kept asking him, are you sure, but what if you are wrong, should we do one more exam, do I need to get a second opinion? And he answered patiently but clearly that I was likely to abort this fetus anytime and it could create a life threatening emergency situation and I should abort the fetus. I was alone and did not have anyone who could help me. College was over, many students were gone home. My husband and I had recently moved from the dorm where we lived to our new house, far in the suburbs and I could not think of anyone who could help me. 

I contacted one friend who also graduated with doctorate, with me and requested her to drive me a day later to the doctor. She agreed. However, that night she called me to say that her boyfriend invited her to go on an outing and she could not take me to the doctor. I literally had no one to take me to the emergency D&C procedure. There were no Ubers in those days. During my studies, I worked as a career counselor. After much thought, I contacted one woman who had come to me for career guidance and was very impressed with me. She was a prominent doctor’s wife who had been out of career life and now that her children were grown and busy in their own lives, she wanted to jumpstart her career and take some courses at the university. 

I called Mrs. doctor and shared my situation with her and also told her that the day after this D&C procedure I was to fly to Minneapolis. She said, she will call back in a few minutes. She soon called me and said  “ Tomorrow morning, pack a small bag and be ready. I have a class but my husband is off. So he will pick you up and take you to the hospital. He can hang out in his office while you go through the procedure and then he will bring you to our home. There is no point for you to go to your empty house. Just come here after the procedure and rest and next day, I will drop you at the airport for your flight to Minneapolis”. I was enormously grateful to her. 

I wanted this child so much that the rest of the day I talked to my baby and I cried. I was going through this ordeal totally alone and I survived because of the help of strangers.

Well, that was what happened so many years ago, in the reddest of the red state of Ohio. However, TODAY if I was in Texas or Idaho or Georgia or any of the red states in the USA and was in a similar predicament then what would be my fate?

First, I would not have anyone to help me, even take me to the doctor. And I mean, NO ONE. I could not ask anyone to help in all fairness because ANYONE WHO WOULD JUST GIVE ME A RIDE WOULD FACE PROSECUTION, JAIL, & FINES. Even an Uber driver couldn’t be asked. If my doctor friend was to take me then he would lose his license. From several states, I would not be allowed to travel when pregnant in this condition. I would literally have to wait at home until the process of abortion started on its own. Let us say that the bleeding began. Then I would summon an ambulance and eventually face huge ambulance bills for them to drive me to the hospital. In the hospital, in several states, the medical staff would be required to watch helplessly as my body tried to abort the fetus and as I would be writhing in pain for no good reason. In some cases, the doctor may give medication to induce delivery, but even then I would be required to go through intense labor pains as my body tried to abort the fetus, as long as there was even the faintest heartbeat. There was a case where a woman took 10 days to abort an ectopic pregnancy (which is always non-viable) and the staff cannot intervene to speed the process. Her doctor said, we helplessly watched her get sicker and sicker and waited until the fetal heartbeat stopped. In the end, the patient required surgery, lost a huge amount of blood and had to be put on a breathing machine. And medical staff knew from the start that this was a non viable pregnancy and 15 minute procedure would do the job for the same end result.

Let us say the hospital staff would intervene on the justification that the fetus was dying and this procedure was necessary to save mine (mother’s) life. Perhaps in some states, they could. BUT, they can still be sued and they would have to spend their time and resources fighting the charges against them. Attorneys in many hospitals are advising hospital staff to not intervene, no matter what, until the fetal heartbeat stops. In case of some large hospitals, if the medical staff intervenes to save the life of the mother and if they win later in the court, then the charges would be dismissed, BUT they would still be out of pocket for the legal fees. There is no reimbursement for them. ON THE OTHER HAND, IF THEY LOST FOR ANY REASON, and if the people suing can make an argument that death is not in our hands and we should just let things play out then anyone trying to help me would have to reimburse them for attorney fees and ALSO pay $10,000 on top in penalties. Let us not forget that the hospitals would pass on these costs to us, the consumers and we will pay more, while we suffer more and get lesser care for our second tier citizens, the women.

THESE ARE THE LAWS ON THE BALLOT IN MANY STATES, THAT HAVE THE POWER TO DRAG WOMEN TO SECOND CLASS CITIZENSHIP STATUS. With these laws, women will be less safe, less healthy, get lesser quality of care, will likely suffer more pain, will pay more dollars for healthcare, can get criminal record, can jeopardize a family member or a good Samaritan trying to help and in the end, healthcare for us all will likely suffer and we all will likely pay more for less care. I am much relieved that I am not in my child bearing years. But I enjoy many freedoms and economic prosperity because women who came ahead of me and men who envisioned gender equality, fought and stood up for these principles. Are we going to stay silent now OR will we speak up and stand up for the women who will follow us; our daughters, nieces, daughters in law, grand daughters? Let us vote for choice and trust that the hands that rock the cradle are emotionally stronger and mentally more capable to make right decisions for their bodies than the hands that bang the gavel.

JOBS: August, 2022

Software Engineer  w/ experience building products in multi-disciplinary envt – Santa Clara, CA

This is an exciting opening software engineer with experience software & hardware development to design, develop & implement a growing suite of bioanalytical solutions comprised of integrated biochips, proprietary reagents & custom instrumentation. The company is founded by a veteran leader and is developing single molecule detection technology, and is focusing on development & commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. 

Responsibilities: Lead / Support Software, Firmware & UI development aspects related to the development of novel, diagnostic instrument platforms; Develop control/analysis software for RUO (Research Use Only) & FDA regulated instrumentation; Develop / Contribute to a custom user interface for scientific & medical diagnostic systems; Support all aspects of technology transfer to & from internal & external partners; and work with a multidisciplinary team of experts.

Requirements: B.S. with 3+ years of relevant experience (Level I), B.S./M.S. with 7+ years of relevant experience. (Level III). Requirements also include, Significant experience with instrument-related software engineering using C#; Experience with Python programming; Exp w/ industry coding best practices (Git management, unit testing, documentation, etc; Experience developing, implementing, consuming & supporting contracted APIs. Also preferred: Experience with interface standards (e.g. GraphQL, OpenAPI, etc.); Experience with firmware level interaction (e.g. C). Experience with delivering quality conformant software (e.g. SaMD); Experience with complex data analysis challenges; Ability to develop custom equipment with external vendors and/or internal engineering resources.

Assembler – San Jose, CA

Exciting medical device company has an immediate opening for an assembler with primary job function to assemble parts and components used in the manufacture of medical devices.

Requirements: Perform assembly operations requiring fine hand dexterity; Understand and comply with GMP & GDP; Comply with work schedules & report hours worked; Enter date and write notes and other entries legibly; Comply with all written procedures & safety practices; Assist in writing & updating assembly procedures, protocols & checklists: Evaluate problems & make initial recommendations for possible corrective actions; Work with production management & QA to provide feedback; Assure product and process quality by following Quality System procedures; Comply with government regulations. High school or equivalent, 2 + years of experience in Medical Device or Pharmaceutical company, Good written and verbal communication & arithmetic skills are required. Also preferred, Medical Device experience, Mechanical aptitude and General proficiency of Microsoft Excel and Microsoft Word. While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Physical on site presence is required.

R&D Engineer w/ Analytical Instrumentation, Systems Integration Exp – Sunnyvale, CA

There are several exciting opportunities for product development research associate/ technician/ engineers in developing, testing, optimizing and troubleshooting aspects related to novel diagnostics technology platform & to work with novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. The compensation will be competitive and includes stock with a huge potential as well as competitive benefits package. Company is found by a veteran leader and focuses on development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. This role requires working with a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.

Responsibilities

Testing, development and optimization of functional biochips, fluidic cartridges & analytical instruments; Support document prep; Use Good Documentation Practices (GDP) while authoring Experimental summaries, DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations; Process development & optimization related to biomolecular sensing; Support all aspects of technology transfer to & from development partners; Develop, test & execute QC procedures; Process troubleshooting to determine root cause & find possible engineering solutions.

Requirements: MS in bio-, mechanical-, electrical- or chemical engineering, chem or biochem, or related; 5+ years hands-on R&D, engineering or product development and project/ people management experience. Experience in developing custom equipment by collaborating with external vendors or internal engineering resources; hands-on experience in mechanical design and in building & operating electronic systems; Proficiency in CAD design; Experience w/ statistical analysis software as well as with instrument-oriented programming language(s) (e.g. Python; LabView); Experience with standard biotech laboratory and/or manufacturing equipment & working with biological or biochemical systems (e.g. proteins, nucleic-acids, cells and/or bio-organic molecules); Experienced using diverse analytical instruments e.g. oscilloscopes, DAQ interfaces; Experienced in cGMPs & in authoring DOPs, BRs, FRs; Experience in V&V of instruments and processes; and Knowledge of data analysis methods.

Optics & Photonics Research Scientist/ Engineer w/ microfluidics/ lab-on-a-chip Exp – Sunnyvale CA

This is an exciting opening for interdisciplinary research scientist/ engineer with experience in photonics, material science and/or biological applications product development to work in multi-disciplinary team, in developing, testing, optimizing and troubleshooting aspects related to novel diagnostics technology platform & to work with novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. The compensation will be competitive and includes stock with a huge potential as well as a competitive benefits package. Company is founded by a veteran leader & focuses on development & commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.

Responsibilities: Support optofluidic platform technology development, & development of single-molecule detection technology with novel reagents & fluidic cartridges, as well as instrumentation for detection, sample preparation & corresponding software; Support diverse aspects related to mid-stage development of a bio-chip based, optofluidic diagnostics platform; Apply diverse knowledge of design principles, practices & implementation in complex systems & assignments; Design, optimize, test, & support validation of optofluidic chips, optical/fluidic interfaces, sample processing technology & instruments, in collaboration with other groups & external suppliers; Develop, evolve & maintain custom optoelectronic systems used for testing and characterizing optofluidic systems; Analyze & present data including images, time traces, assay flows, optical spectrums; Conduct statistical analysis & build/implement/test models for stochastic, high-volume data; Support all aspects of technology transfer to and from internal and external partners; Interface with internal resources and external vendors to design, test & validate equipment.

Requirements: BS/ MS in bio-, mechanical-, electrical- or chemical engineering, chemistry, physics, biochemistry, or related plus 1-5 years hands-on R&D or engineering experience; Extensive theoretical and hands-on experience in optics/photonics; Experience bridging the fields of photonics/optical engineering, microfluidics/lab-on-a-chip & statistics; Exp in design of optical systems (free space & chip based) & in using simulation software eg. ray tracing software for system design & FEM/FDM/BPM etc for chip design: Proficiency in statistical analysis (e.g. Python, JMP, Matlab, etc.) as well as instrument-oriented programming language(s) (e.g. Python; LabView); Experience in using diverse, analytical instruments such as oscilloscopes, DAQ interfaces, UV-VIS spectrometers, scanning electron microscopes (SEMs), fluorescence microscopes, etc. Expertise in optofluidics, Hands on ability to work-with/manipulate/couple optical fiber and respective components, Proficiency with digital/analogue signals & systems; Experience simulating in Multiphysics environments (e.g. Comsol, Lumerical) and Circuit design and simulation experience are all HUGE PLUSES.

Reliability Engineer

There is an exciting opportunity for senior reliability engineer to support manufacturing of disposable medical device through design, assembly and integration of new equipment. Works closely with Process Engineering, Manufacturing, Vendors and other teams to define, improve and monitor equipment reliability, throughput and process capability. Defines, deploys, monitors, and improves the Preventive Maintenance specifications, SPC on key parameters, bill of material and spare parts requirement. Reviews, analyzes, and investigates equipment related scraps and provides root cause analysis and effective corrective actions. Provides technical assistance in installation, preventative maintenance, and calibration of equipment.

Requirements

• Design and implement equipment upgrade to improve reliability and increase production output
• Lead or be an active team member to drive continuous improvement programs to improve equipment performance and reliability, maximize Mean Productive Time Between Failure (MTBF), and Operational Uptime (AOU), and minimize Mean Time To Repair (MTTR)
• Take ownership of the new equipment specification, technical negotiation with vendors, design and documentation review, installation, and qualification testing and documentation.
• Ensure project is on schedule, and at the same time deliver with the highest quality by proactively identifying and correcting capability, reliability, and Maintenance issues early on. Document lessons learned in an efficient manner
• Develop preventive maintenance procedures to reduce equipment and tooling failures
• Generate and maintain accurate and detailed documentations for equipment installation, maintenance and troubleshooting procedures for reference purposes
• Follow SOP on re-validation of existing equipment, tooling and processes
• Perform Root Cause Analysis and Address CAPA on Manufacturing Non-Conformances
• Support equipment related projects which includes but not limited to:
• Purchasing of new or used equipment, set-up, qualification, and release in production
• Manage multiple projects in manufacturing environment from maintenance of existing machines to specifying, purchasing, and set up of new equipment
• Integration of different equipment aspects (software and hardware)

Education and Job Experience

• BS, or MS degree in mechanical engineering, electrical engineering, computer engineering or equivalent
• 7+ years of experience in Equipment Engineering supporting high volume manufacturing
• Good hands-on systems integration experience, troubleshooting, and start-up and commissioning of equipment into production environment
• Proficient in Solidworks, Autocad, and GD&T
• Experienced in PLC, HMI, motion control, instrumentation, pneumatics, and material handling, including robotics. Allen Bradley, Mitsubishi, Omron, Siemens, Adept or Epson experience is a plus
• Working knowledge of lean manufacturing
• Superior communication skills, (written, verbal and active listening.)
• Highly motivated self-starter, capable of self-management with little to no oversight
• Strong interpersonal skills and proven ability to establish effective cross-functional working relationships. Ability to effectively participate on multi-disciplinary teams and projects
• Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
• Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc. is a plus

internal engineering resources.

Finally, ONLY CANDIDATES PROVIDING A POSITION SPECIFIC COVER LETTER WILL BE CONSIDERED!

Senior Manufacturing Engineer – S. San Jose, CA

Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development has an immediate opening for senior manufacturing enginee, to support the development and production of innovative catheters ensuring high reliability, regulatory adherence, and cost-effective manufacturability.

Requirements: Minimum 10 years history of experience in medical device manufacturing environment; Proficiency in Solidworks; Experience writing protocols & test reports; Experience using inspection and test equipment (vision systems, tensile testing) are required.

Responsibilities: Support manufacturing activities; Spend time on the manufacturing line with the assemblers to improve processes & increase quality; Develop assembly & test fixturing; Create, validate & document new manufacturing processes; Write protocols & test reports; Prepare manufacturing lines for significant scale up; Conduct process verification & validation activities; Initiate failure analysis in manufacturing; Design, write & perform equipment qualifications & process validations; Facilitate transitioning development products to full scale production line; Collaborate with existing suppliers & bring up new ones with an eye towards partnership & efficiency. 

Associate Director/Director Validation – SJ  /QUALITY – QA TEAM

There is an immediate opportunity for Director of Validation in San Jose, CA in a pharmaceutical company with novel drug delivery technology. The company recently had an IPO event and the stock has held very well and the technology holds promise to be a game changing improvement in the quality of care for many patients. The company has a world class team in place. Director of Validation is a hands-on role responsible for the execution of validation activities: To develop & implement harmonized validation processes & practices; Develop a qualified team; Manage validation/qualification of equipment, facilities, utilities, cleaning, sterilization, automated systems, and computer system validation in a cGMP environment. 

Skills & Experiences: 

Responsibilities: Ensure development & implementation of validation strategies & internal SOPs; Write & review qualification & validation documents; Lead & support qualification & validation of cGMP equipment, facilities, utility systems, cleaning & manufacturing processes; Develop & maintain risk based, quality driven procedures & practices; Lead risk assessment activities; Identify, hire & develop, manage & support company’s validation expertise; Support change control program with respect to facility, utilities, equipment, cleaning & computerized systems validation changes; Evaluate validation impact of manufacturing process changes & equipment upgrades; Complete activities related to regulatory filings, production schedules and/or customer needs with respect to facilities, utilities, equipment, computer system validation, etc.; Ensure Quality meets or improves on budget, cost & efficiency targets (KPI’s) in line with business objectives; Support QA activities related to the assigned projects, including, but not limited to: internal and external audits, deviations, change control and CAPAs; Other duties/activities may be necessary to support departmental or company goals. 

Skills & Experience: BS in life science or engineering; 10+ validation exp in bio/pharma industry; 5+ years of supervisory/managerial experience; Knowledge Good Engineering Practices, FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971) & validation such as GAMP 5, 21 CFR Part 11, and ASTM E2500; Knowledge of international & domestic cGMP regulations for pharmaceutical manufacturing; Technical writing, problem solving & analytical skills; Ability to review, analyze, summarize & interpret data, draw conclusions & make decisions/ recommendations; and Experience in project management. 

Quality Assurance – S. SJ

There is an immediate QA position available for support & performance of QA/QS functions/activities and adherence to applicable regulatory standards for medical devices. This is a vascular company founded by a seasoned entrepreneur whose previous company had $1B+ exit. This opportunity will offer competitive salary plus stock with huge potential.

Skills & Experience Required: BS in Science related area; 10+ yrs experience in FDA regulated industry; Exp with Quality Assurance practices & systems; Knowledge of ISO 13485 and FDA 21 CFR 820; MasterControl administration/process ownership; Maintain compliance of a certified QMS related to configuration control, document control, and change control. ASQ Certifications are a plus.

Responsibilities: Support devet & maintenance of QMS, ensuring alignment of corporate operations applicable regulations; Serve as system administrator for MasterControl Electronic Document Management and Training System (EDMS), including responsibility for configuration, user training, account management, training course creation and assignment & assessment of upgrades & patches. Maintain validated state of system throughout system lifecycle. Manage, process & track controlled documents from the Document Change Order (DCO) process until document approval or retirement, including updating related controlled documents; Revise controlled documents as appropriate & ensure timely reviews. Manage electronic approval of records/documents via DocuSign; Monitor & track completion of quality system records including CAPA, Deviation, and NCMR; Monitor training compliance & report any issues to management; Maintain Approved Supplier List (ASL) and ensure supplier files are current; Perform raw data review in support of technical reports and regulatory filings & Issue, track, and perform quarterly audits of laboratory notebooks. Assess corporate operations against quality system regulations, issue identification/ resolution including proper and timely documentation; Prepare quality metrics & reports; Facilitate & conduct internal & external audits; Perform history record review & disposition of device batches. Review/approve facility records as needed (pest control reports, cleaning logs, and environmental monitoring reports & Manage archival of hard-copy records.

Senior Manager CMC, Analytical Development – North San Jose, CA

There is an exciting job opportunity in San Jose, CA, to work on novel projects involving drug-device combinations for treating chronic diseases & participate in method and tech transfer from R&D to Manufacturing as appropriate. This is an exciting opportunity in a rapidly growing company to work with a world class team, on game changing technology with HUGE potential.

Requirements include: BS/MS in sciences PLUS 5+ years relevant bio/pharma experience; biologics analytical development exp in biophysical techniques & analytical characterization of peptides & proteins; solid oral dosage and/or parenteral sustained release formulation exp, exp in process development from early to late phase development; experience of working in GLP/GMP regulated environment, drug-device combination exp; knowledge analytical techniques such as various HPLC modes & detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell-based assays, etc, for product characterization, comparability testing and PK/PD analyses; Exp in method validation and specification setting; Assessing chemical & physical stability of formulations, identifying stability, manufacturability, & performance critical quality attributes. Experience in protein purification & biologic formulation is a plus.

Peru Travel: Cusco, Maras Salt Mines, Machu Picchu, Ollantaytambo, Humantay Lake, Rainbow Mountain, Lake Titicaca

We began our trip to Peru with great enthusiasm. The day we landed in Cusco, we enjoyed a walking tour of the city. Cusco, near the Urubamba Valley of the Andes mountain range is at an elevation of 3,400 meters or 11,200 feet. Many of us who traveled together complained of headaches and did not quite realize that it was altitude sickness.

Cusco city was the capital of the Inca Empire from the 13th century until the 16th century Spanish conquest and was declared a World Heritage Site by UNESCO in 1983. During the walking tour, at every corner there seemed to be a mystical story and time seemed to have stopped. We walked primarily around the main plaza, Plaza de Armas de Cusco. In the center of the Plaza is a giant statue of Pachacuti, the ninth Inca. During his reign, the Inca empire grew to nearly the whole of Western South America. It was Pachacuti who is believed to have built Machu Picchu as his estate.

It was absolutely incredible to see colonial and pre colonial structures and walls built with gigantic rocks so well placed and infused together, without the use of mortar and cement. While the large cathedral facing the statue of Pachacuti is an amazing example of colonial goldwork and carved wooden altars. We saw a museum and a convent. Soon we all felt tired and in need of food. We enjoyed a good meal at a local restaurant. Our guide gave us instructions on how to get to the hotel. We were trying to navigate our way to the hotel and lost one of our fellow travelers. We found that phones weren’t working well. In desperation, we searched up and down and finally were able to get the phone to work, connected with her and were united again and reached the hotel. 

Every hotel keeps ready coca leaves tea available upon arrival and the locals say it helps get over the altitude sickness faster. However, my headache wasn’t quite subsiding. Next day, we visited an archeological site called Moray in the Sacred Valley. The site had terraced circular depressions that we get to see at several Inca sites. There has been some debate regarding the purpose of these magnificent depressions but many seem to feel that these sites were made for communal farming as they also feature irrigation systems.

We then visited Maras Salt Mines. This awe-inspiring landscape features salt pans that are still used in the same way as at the time of the Incas; different types of salts completely mined by human effort. Apparently this is some of the best salt in the world. We all shopped for different kinds of salts as well as chocolates and other items before returning to the bus for a ride back.

On our next trip, upon seeing the town of Ollantaytambo in the sacred valley on Urubamba River I was so incredulous that I decided Machu Picchu can’t be any more amazing and boy was I wrong.  Massive Inca fortress at Ollantaytambo with large stone terraces was an amazing sight and even more amazing was the gigantic Sun Temple and the Princess Baths fountain.

And yet visit to Aguas Calientes and world renowned Machu Picchu exceeded all expectations. It was absolutely fascinating and for me, the most enjoyable. The town itself is lovely and we enjoyed walking in the plaza. More than 7000 feet above sea level in the Andes Mountains, Pachacuti is believed to have made this stunning estate for himself and his noblemen and their families and it serves as a mighty symbol of the mighty Incan Empire. It is assumed that Machu Picchu built around the 15th century was not visited by any Westerner till the 19th century. The Incas had no written language at the time and no records exist that point to its exact use. Believed widely to be Pachukuti’s estate, it may have been used for about a 100 years and then abandoned as the Spanish conquerors arrived. Machu Picchu was rediscovered much later and was referred to as the “lost city of the Incas”. At Machu Picchu, it seemed humans were competing with the Gods. If the divine can create such amazing terrain with mountain ranges touching the sky and valleys as deep as eyes can see then what can humans create to elevate themselves and also stay in harmony with pachhe mama ( mother earth) and pache tata (father universe)? Incan citadel at Machu Picchu high in the Andes Mountains in Peru, above the Urubamba River valley is simply breathtaking . Built in the 15th century so high in the mountains, it has sophisticated dry-stone walls that fuse huge blocks without the use of mortar. It’s hard to find words to describe amazing nature in tandem with equally amazing man-made miracle.

My altitude sickness really got stronger on our visit to Humantay Lake, a beautiful, crystal clear lake located at the elevation of 13780 feet or 3850 meters. Its bluish turquoise waters originate 100 percent in the glaciers. Despite it being only a moderately challenging hike, straight steep elevation with quick ascent made it very challenging and we all decided the skip the next day’s adventure. Vinicunca or varicolored, Rainbow Mountain, created from sediments and mineral deposits over millions of years ago is believed to have been discovered only about five years ago. It was fascinating to see Badlands National Park in South Dakota and I was absolutely looking forward to seeing Rainbow Mountain in Peru. But it was not to be. We all needed a break and climbing to even higher elevation wouldn’t do good to any of us. We used the day of rest very well and got a massage and enjoyed some shopping time. I went off to explore the city of Cusco on my own and was looking for one of its well known vegan restaurants, when a man invited me to enjoy the meal at the little eatery I came across. I enjoyed a delicious meal there in an outdoor setting. Later we cut fruits purchased from the local market and enjoyed them while playing cards.

Our visit to Lake Titicaca was very pleasant as well as fascinating. Lake Titicaca is the largest freshwater lake in South America and it is the largest lake at the highest elevation in the world. Titicaca is one of less than twenty ancient lakes on earth, and is thought to be a million years old. Lake Titicaca sits 3 810 m above sea level and is situated between Peru to the west and Bolivia to the east. What was truly fascinating was to see a number of small islands made by humans from braided roots of totora. This dried bamboo like totora vegetation has multiple uses. Besides being used in the construction of the islands, people who live on Lake Titicaca also use it for construction of fishing vessels, for cleaning their teeth, in cooking, and for various other needs. Eating the soft white part of the root provides key nutrients to the people who live on that and other bounty from the ocean. And yet the people sorely lack good nutrition, live an incredibly hard life  and many suffer from osteoarthritis and other diseases. Due to human activities, Lake Titicaca is also highly polluted although in 2018, Peru and Bolivia promised to clean it up and now there is greater awareness to stop further pollution.

Around 4000 people are believed to live on various islands in the middle of the lake. I got a similar feeling of fascination coupled with sadness when I visited floating villages on Tonle Sap Lake at Siem Reap in Cambodia. Humans are meant to live on land, not water and perhaps there is enough land for all our need but not enough for our greed. Then these incredibly poor, marginalized people are forced off the land and are forced to make their livelihood on water, with primary means of subsistence acquired through gawking tourists who pry into the most intimate aspects of  their homes, lives and livelihoods. As I said, it was both amazing and fascinating and very sad.  We then proceeded to climb the top of a small mountain at one of the islands and in an incredibly beautiful setting, we enjoyed a delicious meal. We climbed back down on the other side and boarded our ship to return back to the hotel.

Upon return to the hotel, we went again for a lovely, deep tissue and hot stones massage. I went to the market and had a refreshing glass of pomegranate, passionfruit and ginger juice and in the late evening we reached the airport to board our return flights to the USA

Adults be safe w/ your shotguns BUT help our kids be safe w/ #AssaultWeaponsBan

America is a uniquely interesting country. We all can achieve here depending on the effort we put in, fly in wide open sky depending on our ambition, and feel safe in our homes depending on our willingness to have weapons of destruction. I love love love America and the freedoms it represents, provides, makes accessible to us.

With freedoms come responsibilities. Often however, in America, we love our freedom minus the responsibilities. We often feel entitled to our rights minus the responsibilities. Yes, we absolutely must feel SAFE inside our homes. If for some of us that sense of safety is tied to guns then so be it. They shall have their guns (even though most of us today live in vibrant urban centers, in an age of security alarms, with 24/7 house monitoring packages, multiple indoor, outdoor motion sensors that can be monitored and activated remotely at the touch of a button that is on our phones, watches and more, cameras that take pictures of even cats, skunks and big flies. Feeling of safety is a mental condition – no one knows it better than me. If I am home alone, I check my locks a few times. Similarly, some people need guns before they can fall into restful sleep.

However, let us remember guns can fall into the hands of innocent children and if we keep them then we MUST BEAR THE RESPONSIBILITY FOR IT’S SAFE STORAGE.

Let us not forget – we are defending against a SINGLE INTRUDER, not an army. We don’t need automatic or semi automatic assault weapons.

Let us remember – #OurChildrenMatter and they are not hanging out inside homes like us. When they do hang out at homes, they are far far more savvy and use technology to create an environment of safety. BUT OUR KIDS ARE IN SCHOOLS, CONCERTS, LIBRARIES, COLLEGES, SHOPPING MALLS. Due to lax gun laws, mentally unstable people are getting access to weapons like AR15 and mow down our kids at the blink of an eye, even when security response times are often within seconds to a few minutes.

What does it say about us as a society? That over and over and over and over and over we will put our children in harm’s way, just so we can have a sense of safety from imaginary threats? Just for once, let us put ourselves in the shoes of our children.

Here is conversation I had with a Republican friend.
Me: You want people to be safe in their homes right?
He: Yes.
Me: Ok, I get it. Then let them have their guns. But why AR15 a weapon that has been used in most mass casualty events?
He: We are not giving anything to you.
Me: Let us not think of us versus you. Let us think of society as a whole and how it can be safe. And how we can be safe in our homes and our kids can be safe outside.
He: We are not giving anything to you guys.
Me: But I am also concerned about the safety of our kids as I am sure you are too. Then for impact sake, I NAMED OUR FOUR KIDS.
He: AND WE ARE NOT GIVING YOU AN INCH.
Me: But I am talking about safety of ABCD and I NAMED ALL FOUR KIDS AGAIN.
He: AND WE ARE NOT GIVING YOU AN INCH.

At that point, I felt angry, hurt, and almost sad as if I was losing a child…. BUT I REFUSE TO BELIEVE THAT ALL REPUBLICANS FEEL THAT WAY. I know that in larger context of life, political affiliation doesn’t matter and #OurChildrenMatter to all of us. I know that a Republican heart weeps as much as a Democrat heart when kids are ruthlessly annihilated. 

Can we do something together so OUR KIDS ARE SAFE? Mine and yours and theirs? Just simple #SensibleGunLaws that guarantee access to simple guns (rifles and shot guns) to all mentally stable citizens after a reasonable waiting period to avoid crimes of passion, reasonable restrictions on hand guns and bans on automatic or semi-automatic assault weapons as well as proper and thorough background checks before all sales?

Right now I am a single issue voter. I will vote for any politician, Republican or Democrat who will promise to stand up for sensible gun laws and will take on the gun lobby for the sake of our children.

JOBS – March, 2021

Please see my current opportunities below. All opportunities are for local (US based) candidates with valid work visa with all required industry experience.  If you have an interest then please send an email (resume as an attachment). Please find me on Linkedin.

Quality Engineer – South San Jose, CA

Exciting bay area start-up on catheter development to focus on improved outcomes of arterial disease has an immediate opportunity for a manufacturing minded Quality Engineer.

Responsibilities

Support QA/QC/QS functions and activities in a medical device manufacturing environment; Establish purchased materials RI acceptance criteria & perform RI; In-process/final device inspection; Technical Writing for Design History File documents etc, Regulatory & Quality System documents; Design, write & perform equipment qualifications & process validations; establish & maintain equipment calibration & maintenance; support team, contract manufacturers & suppliers with robust & statistically valid testing, sample size selection, monitoring & analysis requirements

Requirements

5+ years medical device work experience (vascular catheter exp preferred), formal statistics training, Validation protocol design & report writing exp, exp to work in & maintain compliance of a certified QMS related to configuration control, document control & change control, enthusiasm for producing cool new products for catheter development. College education preferred.

Quality Assurance Engineer – N. San Jose, CA

The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for pharmaceutical and combination products. This position requires technical expertise in Aseptic Techniques. The Senior Quality Engineer is responsible for performing a quality role for the aseptic manufacturing, quality systems and compliance in accordance with cGMP, related company SOP’s, federal laws, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products. 

Requirements

• Maintain & improve company’s Quality System in accordance with FDA Regulations and ISO 13485 requirements
• Provide hands-on direction for aseptic process and cGMP manufacturing activities 
• Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
• Collaborate with cross functional teams Manufacturing, Engineering, Facilities to ensure adherence to cGMP guidelines
• Conduct investigations for issues associated with audits, lot history records and complaints. Approve manufacturing and testing deviations and investigations 
• Evaluation and support for implementation of new processes, lead continuous improvement of aseptic / sterile processes
• Lead and support qualification and validation of cGMP equipment, facilities, utility systems, analytical test methods, cleaning and manufacturing processes. These duties will include, but are not limited to: the implementation and documentation of these validations and their lifecycle management in compliance with FDA and EU regulations
• Manage the deviation system, perform QA assessment of deviations and ensure that all assessments are completed, review and approve deviation reports
• Assist in the review and approval of lot history records and test records
• Conduct audits at CMO, testing operations and internal audits
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ), summary reports, ensure qualifications are conducted in accordance with the Validation Master Plan
• Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
• Lead the resolution of quality issues related to non-conformance reports and CAPAs
• Develop and initiate sampling procedures and statistical process control methods
• Address systemic quality issues with suppliers or internal groups
• Evaluate product changes for qualification and validation requirements and assist in change implementations
• Other duties/ activities may be necessary to support departmental or company goals

Qualifications

• Bachelor’s degree or higher in Chemistry, Biology, or equivalent scientific discipline
• A minimum of 7 years quality assurance/engineering experience within the pharmaceutical or biopharmaceutical industry is required
• cGMP experience is required
• Experience with performing utility qualification activities for vaporized hydrogen peroxide (VHP) system is preferred Excellent communication skills both oral and written
• Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations
• Experience with FDA Regulations (21 CFR part 820, part 210 and part 211) and ISO Standards (ISO 13485 and ISO 14971) is required
• Experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)

Senior Quality Engineer – N. San Jose, CA

The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.Requirements

• Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
• Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
• Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
• Lead the resolution of quality issues related to non-conformance reports and CAPAs
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
• Provide QE support to production, purchasing and engineering
• Support/lead test method validation activities
• Conduct and support the development and validation of appropriate test methods for product and process performance
• Develop and initiate sampling procedures and statistical process control methods
• Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan
• Address systemic quality issues with suppliers or internal groups
• Oversee calibration and preventive maintenance program
• Assist in the review of lot history records and disposition of product (subassembly and finished goods)
• Work with engineering to develop adequate inspection criteria
• Perform statistical analysis such as capability, gage R&R, and statistical process control
• Evaluate product changes for qualification and validation requirements and assist in change implementations
• Other duties/ activities may be necessary to support departmental or company goals

Education and Job Experience

• A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device,) is required
• BS degree in Engineering is required
• Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
• Experience with non-conformances, CAPA, and Risk Management is required
• Experience in performing test method validation and Gage R&Rs
• Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
• CQE, CQA preferred

Quality Engineer – South San Jose, CA

Exciting bay area start-up on catheter development to focus on improved outcomes of arterial disease has an immediate opportunity for Quality Engineer.

Responsibilities
Support QA/QC/QS functions and activities in a medical device manufacturing environment; Establish purchased materials RI acceptance criteria & perform RI; In-process/final device inspection; Technical Writing for Design History File documents etc, Regulatory & Quality System documents; Design, write & perform equipment qualifications & process validations; establish & maintain equipment calibration & maintenance; support team, contract manufacturers & suppliers with robust & statistically valid testing, sample size selection, monitoring & analysis requirements

Requirements
5+ years medical device work experience (vascular catheter exp preferred), formal statistics training, Validation protocol design & report writing exp, exp to work in & maintain compliance of a certified QMS related to configuration control, document control & change control, enthusiasm for producing cool new products for catheter development. College education preferred.

Director of Regulatory Affairs – San Jose, CA

• This is an exciting opportunity to join a world class team working under veteran leadership on a game changing class 3 drug delivery combination medical device. This opportunity requires unique combination of experience with developing global regulatory strategy and submissions for combination product development plus experience in multiple phases of development in various therapeutic areas, plus experience with biologics. If you have the right experience, this is exciting and potentially high outcome opportunity that will not disappoint.
• Bachelor’s or Master’s degree in a scientific discipline.
• 10-15 years’ experience in Regulatory Affairs in biotechnology & pharmaceutical industry.
• Thorough knowledge of the drug, device and combination product development process with demonstrated experience in developing global regulatory strategy and submissions.
• Experience in multiple phases of development in various therapeutic areas is desirable. 
• Experience with biologics is a must.
• Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
• Ability to communicate and interact effectively across departments and on project team(s).
• Results driven and team-orientated, with the ability to influence outcomes.  

Bioanalytical Lab Research Scientist – San Jose, CA

This is an exciting opportunity for a bioanalytical scientist to join world class team to work on drug-device projects, with the potential to dramatically change patient outcomes. Position, salary, and benefits are commensurate with experience, with possibility of option grants!!

Required: Background in medical device or pharma testing & regulatory development. Experience in preclinical and clinical research is a must. The candidate must have technical training in biochemistry and/or pharmaceutical sciences with experience using lyophilization, Karl Fischer titration, and HPLC. Experience with biochemical analysis such as spectrophotometric and fluorescence immunoassays, and LC-MS is a plus. Also required, degree in biochem or pharma sciences w. 2+ years experience, extensive exp in various analytical techniques & bioanalytical assays.

Responsibilities: Lead projects on biologic formulation, drug product process development; Executes experiments based on protocols and implement; Develop & maintain documentation,  test methods, study protocols, SOPs, worksheets, forms, and reports; Design and manage data from complex experiments including preliminary statistical analysis; literature searches; Maintain lab & assay operations notebook, equipment, supplies, computer files; Support regulatory efforts.

Bioanalytical Lab Scientist – San Jose, CA

There is an exciting opportunity for a bioanalytical scientist to join a team working on drug-device combinations projects w/ potential to change patient outcomes. Attractive benefits package with competitive salary is offered and option grants makes this exciting opportunity. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment. 

Responsibilities: Perform bioanalytical assays for the quantification of the analytes in in-vitro, preclinical and clinical samples; Participate in the development of in vitro/in vivo models by performing a variety of microplate assays independently with minimal supervision; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment.

Required: Background in medical device or pharma & exp in preclinical and clinical research is a must. Also required, background in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS. exp w/ microplate assays is must and experience with Luminex MapX technology is a plus. BS + 3 yrs work exp or MS + 1 yr exp and exp in writing reports & SOPs, knowledge of statistical software like Excel, GraphPad, Prism & Softmax Pro and hands-on exp in automation & liquid handling in a bioanalytical lab is required.

Senior scientist role requires 5+ years work experience.

Pre-clinical Research Associate – San Jose, CA

This is an exciting opportunity to work with a world class team on a game changing technology. It requires specific in vivo research experience in animal biology, preferably with large (non-rodent) animal models and experience in one or more therapeutic areas: Gastrointestinal (GI), Central Nervous System (CNS), Cardiovascular (CV) and metabolic diseases.

Senior Scientist/ Dir (commensurate w exp)
S. San Francisco, CA

Senior Scientist/ Director/ VP (commensurate with experience)

An early stage biotechnology startup with patented technology for engineering mammalian cells to vastly increase productivity for therapeutic proteins & disrupt biologics manufacturing, has two exciting openings. (The company has backing from J&J).

Job Functions: The work will involve vector design & preparation, transfection, cell culture, cloning & screening, flow cytometry & other related molecular and cellular biology techniques. Collaboration with co-workers &  pharmaceutical company customers is essential for this position.

Requirements: Candidate is required to have Ph.D. plus multiple years of experience with cell line creation, mammalian cell culture expertise, know regulatory landscape related to creating & testing cells for GMP manufacturing; exp. with molecular biology techniques for creating vectors & transfecting cells: exp with protein assays, with a goal to further develop the technology toward full commercialization. Experience with flow cytometry, cell banking, transposase transfection methods a huge plus.

Manufacturing Engineer – San Jose, CA

There are two immediate opportunities for Manufacturing Engineer in N and S San Jose, CA. Both are in well funded startups by veteran leaders with a world class team of people. One is in a combination medical device and the other is in a cardio-vascular company.

Senior & Junior Mechanical Engineers – San Jose, CA

A bay area company with world class team, has an exciting opening for Senior & Junior Mechanical Engineers to design, develop & validate semi or fully automated equipment used for scale-up of high volume, disposable devices.

Responsibilities: Develop concepts & ideas for improving tooling, create new tooling, evaluate current manufacturing processes & workflows, take ownership of design, create User Requirements Specs, conduct concept reviews, show proof of concept through prototyping, support test data, coordinate with stakeholders for V&V, launch & documentation, created 3D models, engineering drawings & bills of materials, participate in design FMEA, plan to mitigate risks, and work with outside vendors, machine shops, contract manufacturers.
Requirements: BS in ME plus 3 to 13 years of medical device industry experience with complex mechanical/ electromechanical design, extensive experience with precision mechanisms pneumatics, servo systems, tooling/ fixtures, motors, belts/ pulleys, gears, actuators, sensors and experience creating engineering drawings, BOMs, products specs is required. Also required knowledge of material properties, heat treatment & surface finish, understanding of DFM & lean manufacturing, and track record with medical device manufacturing methods, RDA reqgulations, ISO, cGMP & QMS standards is required. MS in ME, experience with plastic injection molding, knowledge of DOE, SPC, JMP/ Minitab, experience with metal stamping, laser cutting, chemical etching, familiarity with sterilization process & aseptic environment and PLC programming would be a big plus.

Mechanical Engineer R&D – San Jose, CA

Senior Mechanical Engineer is responsible for evaluating and improving the current drug delivery system by testing and optimizing components or sub-assemblies as needed. He/she will work with quality & regulatory to develop complete documentation for the device.

Responsibilities: Evaluate current design & identify opportunities for improvement, show proof of concept through prototyping and supporting test data, document internal design control SOPs, lead V&V activities, create 3D models, engineering drawings & bill of materials, create work instructions & manufacturing SOP’s, work with quality, and outside vendors, machine shops, contract manufacturers and comply with company’s policies & guidelines regarding quality & regulatory.

Qualifications: BS in ME + 5 years hands’on experience in medical device design environment, experience with creating engineering drawings, BOMs, product specs, experience with implementing product into manufacturing, knowledge of FDA regulations & ISO, cGMP, QMS standards, understanding of DFM & lean manufacturing, experience with machine shop tools & SolidWorks. Master’s degree in ME or BME and/or experience with plastic injection molding, a huge plus.

Senior Catheter Design Engineer – S. San Jose, CA

There is an immediate opportunity for a Senior Catheter Design Engineer with 15 to 20 years experience in catheter design engineering in a stealth mode company that is less than 2 years away from getting its first two devices 510 K approved and launched. The company is led by a visionary leader and has highly experienced engineering and management team.  This a huge opportunity to participate at grounds level in what is a truly exciting and game changing technology that is poised to change the quality of care of cardiac patients, with a potential to save millions of healthcare dollars, on regular basis. Experience is IVUS engineering a huge plus.

Manufacturing/ Test/ Quality Engineer – S. San Jose, CA

A stealth mode cardiovascular company with experienced engineering team, led by a serial entrepreneur, has an immediate opening for  Manufaturing/ Test/ Quality Engineer. This requires 10 plus years experience in the filed of catheter engineering.

Catheter Design Mechanical Engineer – S. San Jose, CA

A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an immediate opening for  Catheter Design Mechanical Engineer. The position requires 5 to 10 years of experience in catheter engineering, a can do, problem solving attitude, excellent conflict resolution skills and an ability to handle uncertainty. 

Program/ Project Manager – S. San Jose, CA

A stealth mode cardiovascular company with world class engineering team, led by a veteran leader with prior experience in building a company, has an opening for  Program Manger with experience of working in catheter engineering industry and a demonstrated history of managing projects all the way from conceptualization, team building, cost estimation, implementation, regulatory 510 (K) approval, and production support to launch. Experience in catheter engineering and leading 510K approval program is absolutely essential.

Supply Chain Management/ Strategy Leader – S. San Jose, CA

A stealth mode startup with exciting technology with potential to alter the quality of care of cardiac patients is looking for Supply chain management/ strategy leader. This position requires extensive experience across the end to end supply chain spectrum in Class 3 medical device industry. It requires proven track record of significant contributions to cost reduction and productivity improvement and experience in cross-functional leadership.

Senior Technician/ Manufacturing Engineer – S. San Jose, CA

A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an opening for Senior Technician/ Manufacturing Engineer with 4 plus years experience in catheter engineering. 

NGS Research Scientist – Foster City, CA

Job Functions: To work on NGS assays for RNA seq, single cell and immune profiling projects & work collaboratively to develop new assays based on requests from the commercial team. Design & execute on NGS assays including 10X single cell & TCR/BCR repertoire profiling; Perform proof-of-concept experiments to enable development of new NGS applications for epigenetic and immunotherapy solutions; Collaborate w bioinformatics scientists to assist in data interpretation for single cell & TCR projects & generate presentations & reports for commercial projects; Generate data for application notes for marketing & BD needs.

Qualifications: Masters in Genetics, Immunology, Cancer Biology, Molecular Biology or related field; 2+ yrs NGS experience. Also, Hands-on experience in NGS techniques including sample extractions, RNA-seq, 10X, library prep & exp in low-input & single-cell NGS applications & exp in designing, executing, & troubleshooting for molecular & cell biology techniques a plus.

Mechanical Testing & Fixture Design  Engineer – Milpitas, CA

There is an immediate opening for mechanical testing and fixture design engineer. Good understanding of how to design and set up tests is required. Responsibilities include design unique tests, develop fixtures, report failtures, help improve manufacturing processes, support V&V testing, interface with manufacturing to implement new design updates into pilot manufacturing line and analyze data. BS in ME, fluency in SolidWorks, and 3-5 years of medical device industry experience is required.

JOBS – December, 2020

Please see my current opportunities below. All opportunities are for local (US based) candidates with valid work visa with all required industry experience.  If you have an interest then please send an email (resume as an attachment) at wd under score darshana at hot mail or find me on Linkedin.

Project Manager – North San Jose, CA – hot

There is an exciting opportunity for Project Manager to lead the successful execution & launch of engineering projects in a fast paced environment. This position has responsibility for daily management of complex projects & requires a high degree of coordination with a cross-functional team.

Responsibilities: Oversee & drive multiple engineering projects from initiation through validation & product release; Develop realistic project schedules w/ resource plan, risk mgmt, & measurable metrics; Communicate progress & coordinate interdependent tasks & deliverables w stakeholders; Lead meetings, plan agendas, presentations & action items and deliverables; Comply w/ company policies on design control & validation activities & documentation.

Requirements: BS in engineering or related; 7-10 yrs exp w/ managing engineering projects & standard project mgmt methods, tools & software packages; strong people & negotiation skills, leadership skills, self motivated, adaptable, flexible, creative, strong technical problem solving abilities; Able to handle multiple projects w/ organizational & time mgmt; Fluency w/ Excel, Word, PowerPoint & Visio; Proven track record w/ medical device, FDA regulations, ISO, cGMP & QMS standards; In-depth understanding of V&V (IQ, OQ, PQ & risk analysis (FMEA). Preferred: PMP certification, Exp w/ Visual Project Mgmt; Exp w/ turnkey, capital equipment; Familiarity w/ sterilization process & aseptic manufacturing.

Director of Regulatory Affairs – North San Jose, CA hot

There is an exciting opportunity for Director of Regulatory Affairs in a drug delivery company in San Jose, CA that is responsible for development of global regulatory strategy, managing RA activities (nonclinical & clinical), for investigational drug-device combination products from preclinical through product approval & RA submissions. 

Functions: Develop & execute regulatory strategies for earliest possible approvals; Help translate local, regional & international regulatory reqs in workable plans; Plan strategy for product registration & submissions to health authorities worldwide; Interact cross-functionally; Prep filings of INDs, CTAs, BLAs, NDAs, MAA etc.; Exp in CMC regulatory compliance; Review clinical trial documents, protocols, reports, brochures, Review & approve clinical manufacturing plans & labeling & authorize drug shipment to clinical sites; Liaise w/ regulatory agencies for review & approval of plans, timely resolution of issues & approval of marketing; Manage regulatory timelines; Interface w/ international affiliates; Maintain knowledge of global competitive landscape & regulatory environment.

Requirements: BS or MS in a scientific discipline, 10-15 yrs exp in RA in biotech or pharma, Knowledge of drug device combination products and exp in global regulatory strategy & submissions, Exp in multiple phases of devt in various therapeutic areas, Exp w/ biologics (this is a must); Ability to travel.

Quality Engineer – North San Jose, CA

There is immediate opportunity for Quality Engineer in well funded startup by a veteran leader with a world class team. JD will be posted soon but meanwhile please send CV.

Quality Engineer – South San Jose, CA – urgent

Exciting bay area start-up on catheter development to focus on improved outcomes of arterial disease has an immediate opportunity for Quality Engineer.

Responsibilities
Support QA/QC/QS functions and activities in a medical device manufacturing environment; Establish purchased materials RI acceptance criteria & perform RI; In-process/final device inspection; Technical Writing for Design History File documents etc, Regulatory & Quality System documents; Design, write & perform equipment qualifications & process validations; establish & maintain equipment calibration & maintenance; support team, contract manufacturers & suppliers with robust & statistically valid testing, sample size selection, monitoring & analysis requirements

Requirements
5+ years medical device work experience (vascular catheter exp preferred), formal statistics training, Validation protocol design & report writing exp, exp to work in & maintain compliance of a certified QMS related to configuration control, document control & change control, enthusiasm for producing cool new products for catheter development. College education preferred.

Bioanalytical Lab Research Scientist – San Jose, CA – hot

This is an exciting opportunity for a bioanalytical scientist to join world class team to work on drug-device projects, with the potential to dramatically change patient outcomes. Position, salary, and benefits are commensurate with experience, with possibility of option grants!!

Required: Background in medical device or pharma testing & regulatory development. Experience in preclinical and clinical research is a must. The candidate must have technical training in biochemistry and/or pharmaceutical sciences with experience using lyophilization, Karl Fischer titration, and HPLC. Experience with biochemical analysis such as spectrophotometric and fluorescence immunoassays, and LC-MS is a plus. Also required, degree in biochem or pharma sciences w. 2+ years experience, extensive exp in various analytical techniques & bioanalytical assays.

Responsibilities: Lead projects on biologic formulation, drug product process development; Executes experiments based on protocols and implement; Develop & maintain documentation,  test methods, study protocols, SOPs, worksheets, forms, and reports; Design and manage data from complex experiments including preliminary statistical analysis; literature searches; Maintain lab & assay operations notebook, equipment, supplies, computer files; Support regulatory efforts.

Bioanalytical Lab Scientist – San Jose, CA – urgent

There is an exciting opportunity for a bioanalytical scientist to join a team working on drug-device combinations projects w/ potential to change patient outcomes. Attractive benefits package with competitive salary is offered and option grants makes this exciting opportunity. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment. 

Responsibilities: Perform bioanalytical assays for the quantification of the analytes in in-vitro, preclinical and clinical samples; Participate in the development of in vitro/in vivo models by performing a variety of microplate assays independently with minimal supervision; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment.

Required: Background in medical device or pharma & exp in preclinical and clinical research is a must. Also required, background in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS. exp w/ microplate assays is must and experience with Luminex MapX technology is a plus. BS + 3 yrs work exp or MS + 1 yr exp and exp in writing reports & SOPs, knowledge of statistical software like Excel, GraphPad, Prism & Softmax Pro and hands-on exp in automation & liquid handling in a bioanalytical lab is required.

Senior scientist role requires 5+ years work experience.

Senior Scientist/ Dir/ VP – S. San Francisco, CA – urgent

Senior Scientist/ Director/ VP (commensurate with experience)

An early stage biotechnology startup with patented technology for engineering mammalian cells to vastly increase productivity for therapeutic proteins & disrupt biologics manufacturing, has two exciting openings. (The company has backing from J&J).

Job Functions: The work will involve vector design & preparation, transfection, cell culture, cloning & screening, flow cytometry & other related molecular and cellular biology techniques. Collaboration with co-workers &  pharmaceutical company customers is essential for this position.

Requirements: Candidate is required to have Ph.D. plus multiple years of experience with cell line creation, mammalian cell culture expertise, know regulatory landscape related to creating & testing cells for GMP manufacturing; exp. with molecular biology techniques for creating vectors & transfecting cells: exp with protein assays, with a goal to further develop the technology toward full commercialization. Experience with flow cytometry, cell banking, transposase transfection methods a huge plus.

Manufacturing Engineer

There is immediate opportunity for Manufacturing Engineer in San Jose, CA, in a well funded startup by a veteran leader with a world class team. JD will be posted soon but meanwhile please send CV.

Senior & Junior Mechanical Engineers – San Jose, CA

A bay area company with world class team, has an exciting opening for Senior & Junior Mechanical Engineers to design, develop & validate semi or fully automated equipment used for scale-up of high volume, disposable devices.

Responsibilities: Develop concepts & ideas for improving tooling, create new tooling, evaluate current manufacturing processes & workflows, take ownership of design, create User Requirements Specs, conduct concept reviews, show proof of concept through prototyping, support test data, coordinate with stakeholders for V&V, launch & documentation, created 3D models, engineering drawings & bills of materials, participate in design FMEA, plan to mitigate risks, and work with outside vendors, machine shops, contract manufacturers.
Requirements: BS in ME plus 3 to 13 years of medical device industry experience with complex mechanical/ electromechanical design, extensive experience with precision mechanisms pneumatics, servo systems, tooling/ fixtures, motors, belts/ pulleys, gears, actuators, sensors and experience creating engineering drawings, BOMs, products specs is required. Also required knowledge of material properties, heat treatment & surface finish, understanding of DFM & lean manufacturing, and track record with medical device manufacturing methods, RDA reqgulations, ISO, cGMP & QMS standards is required. MS in ME, experience with plastic injection molding, knowledge of DOE, SPC, JMP/ Minitab, experience with metal stamping, laser cutting, chemical etching, familiarity with sterilization process & aseptic environment and PLC programming would be a big plus.

Mechanical Engineer R&D – San Jose, CA

Senior Mechanical Engineer is responsible for evaluating and improving the current drug delivery system by testing and optimizing components or sub-assemblies as needed. He/she will work with quality & regulatory to develop complete documentation for the device.

Responsibilities: Evaluate current design & identify opportunities for improvement, show proof of concept through prototyping and supporting test data, document internal design control SOPs, lead V&V activities, create 3D models, engineering drawings & bill of materials, create work instructions & manufacturing SOP’s, work with quality, and outside vendors, machine shops, contract manufacturers and comply with company’s policies & guidelines regarding quality & regulatory.

Qualifications: BS in ME + 5 years hands’on experience in medical device design environment, experience with creating engineering drawings, BOMs, product specs, experience with implementing product into manufacturing, knowledge of FDA regulations & ISO, cGMP, QMS standards, understanding of DFM & lean manufacturing, experience with machine shop tools & SolidWorks. Master’s degree in ME or BME and/or experience with plastic injection molding, a huge plus.

Senior Catheter Design Engineer – S. San Jose, CA – urgent

There is an immediate opportunity for a Senior Catheter Design Engineer with 15 to 20 years experience in catheter design engineering in a stealth mode company that is less than 2 years away from getting its first two devices 510 K approved and launched. The company is led by a visionary leader and has highly experienced engineering and management team.  This a hug opportunity to participate at grounds level in what is a truly exciting and game changing technology that is poised to change the quality of care of cardiac patients, with a potential to save millions of healthcare dollars, on regular basis. Experience is IVUS engineering a huge plus.

Manufacturing/ Test/ Quality Engineer – S. San Jose, CA

A stealth mode cardiovascular company with experienced engineering team, led by a serial entrepreneur, has an immediate opening for  Manufaturing/ Test/ Quality Engineer. This requires 10 plus years experience in the filed of catheter engineering.

Catheter Design Mechanical Engineer – S. San Jose, CA

A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an immediate opening for  Catheter Design Mechanical Engineer. The position requires 5 to 10 years of experience in catheter engineering, a can do, problem solving attitude, excellent conflict resolution skills and an ability to handle uncertainty. 

Program/ Project Manager – S. San Jose, CA

A stealth mode cardiovascular company with world class engineering team, led by a veteran leader with prior experience in building a company, has an opening for  Program Manger with experience of working in catheter engineering industry and a demonstrated history of managing projects all the way from conceptualization, team building, cost estimation, implementation, regulatory 510 (K) approval, and production support to launch. Experience in catheter engineering and leading 510K approval program is absolutely essential.

Supply Chain Management/ Strategy Leader – S. San Jose, CA

A stealth mode startup with exciting technology with potential to alter the quality of care of cardiac patients is looking for Supply chain management/ strategy leader. This position requires extensive experience across the end to end supply chain spectrum in Class 3 medical device industry. It requires proven track record of significant contributions to cost reduction and productivity improvement and experience in cross-functional leadership.

Senior Technician/ Manufacturing Engineer – S. San Jose, CA

A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an opening for Senior Technician/ Manufacturing Engineer with 4 plus years experience in catheter engineering. 

NGS Research Scientist – Foster City, CA

Job Functions: To work on NGS assays for RNA seq, single cell and immune profiling projects & work collaboratively to develop new assays based on requests from the commercial team. Design & execute on NGS assays including 10X single cell & TCR/BCR repertoire profiling; Perform proof-of-concept experiments to enable development of new NGS applications for epigenetic and immunotherapy solutions; Collaborate w bioinformatics scientists to assist in data interpretation for single cell & TCR projects & generate presentations & reports for commercial projects; Generate data for application notes for marketing & BD needs.

Qualifications: Masters in Genetics, Immunology, Cancer Biology, Molecular Biology or related field; 2+ yrs NGS experience. Also, Hands-on experience in NGS techniques including sample extractions, RNA-seq, 10X, library prep & exp in low-input & single-cell NGS applications & exp in designing, executing, & troubleshooting for molecular & cell biology techniques a plus.

Mechanical Testing & Fixture Design  Engineer – Milpitas, CA

There is an immediate opening for mechanical testing and fixture design engineer. Good understanding of how to design and set up tests is required. Responsibilities include design unique tests, develop fixtures, report failtures, help improve manufacturing processes, support V&V testing, interface with manufacturing to implement new design updates into pilot manufacturing line and analyze data. BS in ME, fluency in SolidWorks, and 3-5 years of medical device industry experience is required.

JOBS: October, 2020

Please see my current opportunities below. All opportunities are for local (US based) candidates with valid work visa with all required industry experience.  If you have an interest then please send an email (resume as an attachment) at wd under score darshana at hot mail or find me on Linkedin.

Senior & Junior Mechanical Engineers

A bay area company with world class team, has an exciting opening for Senior & Junior Mechanical Engineers to design, develop & validate semi or fully automated equipment used for scale-up of high volume, disposable devices.

Responsibilities: Develop concepts & ideas for improving tooling, create new tooling, evaluate current manufacturing processes & workflows, take ownership of design, create User Requirements Specs, conduct concept reviews, show proof of concept through prototyping, support test data, coordinate with stakeholders for V&V, launch & documentation, created 3D models, engineering drawings & bills of materials, participate in design FMEA, plan to mitigate risks, and work with outside vendors, machine shops, contract manufacturers.
Requirements: BS in ME plus 3 to 13 years of medical device industry experience with complex mechanical/ electromechanical design, extensive experience with precision mechanisms pneumatics, servo systems, tooling/ fixtures, motors, belts/ pulleys, gears, actuators, sensors and experience creating engineering drawings, BOMs, products specs is required. Also required knowledge of material properties, heat treatment & surface finish, understanding of DFM & lean manufacturing, and track record with medical device manufacturing methods, RDA reqgulations, ISO, cGMP & QMS standards is required. MS in ME, experience with plastic injection molding, knowledge of DOE, SPC, JMP/ Minitab, experience with metal stamping, laser cutting, chemical etching, familiarity with sterilization process & aseptic environment and PLC programming would be a big plus.

Mechanical Engineer R&D – San Jose, CA

Senior Mechanical Engineer is responsible for evaluating and improving the current drug delivery system by testing and optimizing components or sub-assemblies as needed. He/she will work with quality & regulatory to develop complete documentation for the device.

Responsibilities: Evaluate current design & identify opportunities for improvement, show proof of concept through prototyping and supporting test data, document internal design control SOPs, lead V&V activities, create 3D models, engineering drawings & bill of materials, create work instructions & manufacturing SOP’s, work with quality, and outside vendors, machine shops, contract manufacturers and comply with company’s policies & guidelines regarding quality & regulatory.

Qualifications: BS in ME + 5 years hands’on experience in medical device design environment, experience with creating engineering drawings, BOMs, product specs, experience with implementing product into manufacturing, knowledge of FDA regulations & ISO, cGMP, QMS standards, understanding of DFM & lean manufacturing, experience with machine shop tools & SolidWorks. Master’s degree in ME or BME and/or experience with plastic injection molding, a huge plus.

Senior Catheter Design Engineer – S. San Jose, CA

There is an immediate opportunity for a Senior Catheter Design Engineer with 15 to 20 years experience in catheter design engineering in a stealth mode company that is less than 2 years away from getting its first two devices 510 K approved and launched. The company is led by a visionary leader and has highly experienced engineering and management team.  This a hug opportunity to participate at grounds level in what is a truly exciting and game changing technology that is poised to change the quality of care of cardiac patients, with a potential to save millions of healthcare dollars, on regular basis. Experience is IVUS engineering a huge plus.

Manufacturing/ Test/ Quality Engineer – S. San Jose, CA

A stealth mode cardiovascular company with experienced engineering team, led by a serial entrepreneur, has an immediate opening for  Manufaturing/ Test/ Quality Engineer. This requires 10 plus years experience in the filed of catheter engineering.

Catheter Design Mechanical Engineer – S. San Jose, CA

A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an immediate opening for  Catheter Design Mechanical Engineer. The position requires 5 to 10 years of experience in catheter engineering, a can do, problem solving attitude, excellent conflict resolution skills and an ability to handle uncertainty. 

Program/ Project Manager – S. San Jose, CA

A stealth mode cardiovascular company with world class engineering team, led by a veteran leader with prior experience in building a company, has an opening for  Program Manger with experience of working in catheter engineering industry and a demonstrated history of managing projects all the way from conceptualization, team building, cost estimation, implementation, regulatory 510 (K) approval, and production support to launch. Experience in catheter engineering and leading 510K approval program is absolutely essential.

Supply Chain Management/ Strategy Leader – S. San Jose, CA

A stealth mode startup with exciting technology with potential to alter the quality of care of cardiac patients is looking for Supply chain management/ strategy leader. This position requires extensive experience across the end to end supply chain spectrum in Class 3 medical device industry. It requires proven track record of significant contributions to cost reduction and productivity improvement and experience in cross-functional leadership.

Senior Technician/ Manufacturing Engineer – S. San Jose, CA

A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an opening for Senior Technician/ Manufacturing Engineer with 4 plus years experience in catheter engineering. 

NGS Research Scientist – Foster City, CA

Job Functions: To work on NGS assays for RNA seq, single cell and immune profiling projects & work collaboratively to develop new assays based on requests from the commercial team. Design & execute on NGS assays including 10X single cell & TCR/BCR repertoire profiling; Perform proof-of-concept experiments to enable development of new NGS applications for epigenetic and immunotherapy solutions; Collaborate w bioinformatics scientists to assist in data interpretation for single cell & TCR projects & generate presentations & reports for commercial projects; Generate data for application notes for marketing & BD needs.

Qualifications: Masters in Genetics, Immunology, Cancer Biology, Molecular Biology or related field; 2+ yrs NGS experience. Also, Hands-on experience in NGS techniques including sample extractions, RNA-seq, 10X, library prep & exp in low-input & single-cell NGS applications & exp in designing, executing, & troubleshooting for molecular & cell biology techniques a plus.

Logistics Lab Associate – Foster City, CA

This position will report to the Lab Manager & will handle procurement, distribution, storage, delivery & inspection of incoming & outgoing products to the lab. 

Responsibilities: Maintain inventory system, procure lab supplies from verified vendors, provide monthly reporting, execute POs, drive cost optimization, negotiate w/ vendors/ service providers, liaise w/ lab scientists on inventory, for example, ensure kits/reagents are not expired, manage iSensix alarms, store items appropriately & efficiently, & keep in stock at all times general use items (such as gloves, pipette tips, PCR plates, etc), track NGS inventory, meet reporting deadlines, generate & discuss reports w/ lab managers, handle shipment of  receipts & support facility initiatives. Requires ability to move/ stock supplies weighing up to 45 lbs.

Requirements: Ability to work independently, 2-5 years prior work experience as lab assistant at biotech/ diagnostic/ pharma/ lab, attention to detail in written instructions & documentation, basic computer skills in Word, Excel, willingness to work in two different time zones.

Senior Electro-Mechanical Engineering Technician – San Jose, CA

Requires 15+ years of experience.

Mechanical Testing & Fixture Design  Engineer – Milpitas, CA

There is an immediate opening for mechanical testing and fixture design engineer. Good understanding of how to design and set up tests is required. Responsibilities include design unique tests, develop fixtures, report failtures, help improve manufacturing processes, support V&V testing, interface with manufacturing to implement new design updates into pilot manufacturing line and analyze data. BS in ME, fluency in SolidWorks, and 3-5 years of medical device industry experience is required.

Patent Attorney

This position will be responsible for preparing patent applications and will prosecute company’s global patent portfolio. 3+ years of medical device industry experience as a scientist or engineer plus 3+ years of experience as a patent prosecutor is required. Also required USPTO registration and CA license. Highly preferred, 3+ years experience designing/ developing medical devices and at least 3-% of patent prosecution experience across a variety of medical devices and a basic understanding of pharmacodynamics and pharmacokinets and a degree in EE or material science.

Leadership Opportunity – Milpitas, CA

There is a senior level leadership opportunity that requires prior experience with leading a neurological medical device company.

Leadership Opportunity – Union City, CA

A senior level leadership opportunity requires experience with taking a biotech company public.

For here or to go? Movie Review

Not only do we humans get used to an easier life with some comforts, but when we begin to get settled in a place where we begin to build our career in our youth and make friends and build aspirations then we’re simultaneously not planning an alternate lifestyle. However, students who come to study in the US are stuck in a limbo of uncertainty for years, and among them are over a million young people from India. Pulled between a sense of cultural displacement, strong familial ties back home and climbing the career ladder of success in the US, their dreams are just beginning to come into a sharper focus as they enter the world of work, after completion of their studies. 

When the recession hit in 2008, young Vivek Pandit (Ali Fazal) with brilliant ideas for a tech startup, encountered problems with his visa renewal. Faced with the prospect of going home, his friends advise him that If the job is over then they have to be ready to leave. Life in a different society will call for different priorities and accordingly they say, “Go to the Golden gate, and take a few pics that you can also use for shadi.com (Indian matrimonial site)”.

Vivek’s accidental meeting with Shweta  (Melanie Kannokada), a second generation Indian or ABCD as they are called by desi circles, results in a sprouting romance. However, Vivek’s uncertain future suddenly ends a relationship that looked promising. Vivke laments, “Temporary is not how you feel living here, it’s also how others see you”. Meanwhile, Shweta’s author father Vishwanath Prabhu (Rajit Kapur) is on a speaker’s circuit advising young Indians to return home and make a difference in India.

Vivek’s townhouse roommates include Sam (Samrat Chakrabarti), a gay co-worker Lakshmi (Omi Vaidya), and Amit (Amitosh Nagpal). Their innocent mistake or allowing a friend who is an illegal immigrant, lands them on the FBI’s watch list. Each of them is also navigating a set of cultural and practical challenges. Omi is reluctant to visit his family back home, from the fear that he may be pressured to get married and they will not accept his being gay. Amit has to present his passport to the FBI but has misplaced it.

As the movie progresses it begins to become clearer that among the blessings these young people have are their families who care deeply for their happiness and love and support of friends who are stuck in similar moral dilemmas and navigating practical challenges. Amit bring many lighter moments. Living in a shadow of uncertainty he says, Zindagi sirf guarantee pe nahi, umido pe bhi chalti hai (life doesn’t just run on certainly, it also unravels on the basis of hope).

Writer-producer Rishi S. Bhilawadikar’s script is fast moving and hits a range of diverse points that highlight the complexities of living a life of uncertainty. Director Rucha Humnabadkar has avoided over-dramatizing any of these challenges, while maintaining focus. 

In the end, what you are impressed with is the quiet tenacity and adaptability of these bright young people. Vivek says, Akhir zindagi sirf umiddo pe nahi, apni nazariya pe bhi to chalti hai (after all, life doesn’t just unfold on the basis of hope, but also unravels as per your perspective and efforts).

દ્રષ્ટિકોણ – હેન્રીએટ્ટા લેક્સ નું અમર જીવન (Immortal Life of Henrietta Lacks in #Gujarati)

જો આ કોરોનવાઈરસ ના સમય માં નવાઈ લાગે કે એક આવડું એવું અમથું જંતુ આવો ભય મચાવી દ્યે તો આજે એક બીજી ઘટના ની વાત કરીએ.  તેનો કોરોનવાઈરસ સાથે નો સબંધ એટલો જ કે કોઈપણ જીવંત વસ્તુ ક્યારે અનહદ અને અમર્યાદિત રીતે વાતાવરણમાં ચારેકોર ફેલાવા લાગે તે જાણવું અઘરું છે. 

1961 ની સાલ માં હેન્રીએટ્ટા લેક્સ કરીને એક આફ્રિકન અમેરિકન મહિલાને કેન્સર થયું અને એકદમ જલ્દીથી તેના શરીરમાં ફેલાવા લાગ્યું।  કુટુંબની અથાગ સારવાર અને ડોક્ટરોની મહેનત છતાં કેન્સર રોકાયા વગર એકદમ જલ્દી ફેલાતું રહ્યું અને ટૂંક સમય માંજ તેનું અવસાન થયું।  ડોકટોરોને રિસર્ચ માટે તેના સેલ્સ જોઈતા હતા. તેમણે થોડી માત્રામાં તે સેલ્સ તેના શરીર માંથી કાઢી લીધા અને તેમની ઉપર રિસર્ચ કરવાનું શરુ કર્યું। 

આપણા શરીરમાં લગભગ એક કરોડ ટ્રિલિયન સેલ્સ (કોષો) હોય છે. આ સેલ્સ  આપણા શરીરની પેશીઓ, સ્નાયુઓ, અસ્થિ, લોહી, અને અંગો બનાવે છે. દરેક કોષમાં સાયટોપ્લાઝમ અને ન્યુક્લિયસનો સમાવેશ થાય છે. ન્યુક્લિયસમાં તમામ આનુવંશિક માહિતી (જેનેટિક કોડ) હોય છે, જે દરેક કોષના દરેક ન્યુક્લિયસમાં વ્યક્તિના સંપૂર્ણ જીનોમની સમાન નકલ હોય છે. સેલ વિભાગ અથવા મિટોસિસ નવા કોશિકાઓના વિકાસ શક્ય બનાવે છે. પરંતુ આ વિભાજન પ્રક્રિયામાં એક નાની ભૂલ, એક એન્ઝાઇમ misfiring, એક ખોટી પ્રોટીન સક્રિયકરણ પ્રક્રિયાને ને લીધે થતી કોઈ ભૂલ શરીર ને કેન્સર તરફ દોરી જય શકે છે. હેનરીટ્ટાના કેન્સર કોશિકાઓ તેમના ગાંઠમાંથી લેવામાં આવી હતી અને વૈજ્ઞાનિકોમાં સંશોધન માટે મુક્ત રીતે વહેંચવામાં આવી અને તેને હીલા સેલ્સ નામ આપવામાં આવ્યું.

હેન્રીએટ્ટા નું કેન્સર એટલું ઝડપથી ફેલાયું હતું કે વૈજ્ઞાનિકો ને જાણ હતી કે હેન્રીએટ્ટા ના હીલા સેલ ખુબજ શક્તિશાળી હતા અને તેને અમર સેલ રેખા તરીકે નામ આપ્યું. પણ જયારે આવા પ્રભાવશાળી હિલા કોષો વૈજ્ઞાનિકોમાં, સંશોધન માટે મુક્તપણે વિતરણ કરવામાં આવ્યા ત્યારે  કેટલી હદ સુધી તે અમર સેલ રેખા હતી તે કોઈને ખબર નહિ. સંશોધકો તેમને હર્પીસ, મિસલ્સ, મમ્પ્સ, પોક્સ, એન્સેફાલીટીસ અને પોલિયો જેવા તમામ પ્રકારનાં વાઇરસ સાથે સાથે અભ્યાસ કરતા હતા. તે પછી તો તેઓ બીજી સેલ લાઈન અન્ય કોશિકાઓ, બીજા દર્દીઓના શરીરમાંથી લઈને અને તેને વિકસાવીને પણ રિસર્ચ કરવા લાગ્યા। પણ એક વાત તેમના ધ્યાન બહાર રહી. અને તે એ કે હીલા કોષો એટલા શક્તિશાળી હતા કે લેબોરેટરી માં રહેલ ઘણી બધી બીજી સેલ લાઈન હિલા સેલ થી દૂષિત થઈ જતી હતી અને કદી કોઈ પણ રીતે ના મરનાર હિલ સેલ બધેજ પ્રસારીને પોતાનું વર્ચસ્વ જમાવી દેતા. 

1966 માં ગટૅલ નામના વૈજ્ઞાનિકે પુરવાર કર્યું કે ઘણી સેલ લાઈન ઉપર વૈજ્ઞાનિકો અભ્યાસ કરી રહ્યા હતા તેમાંથી મોટા ભાગની હિલા લાઈન થી દુષિત થઇ ગયેલી। એટલે કે વૈજ્ઞાનિકો સમજતા હતા કે તે નવી રિસર્ચ કરી રહ્યા છે પણ તે બધી રિસર્ચ હિલા ઉપર જ થઇ રહી હતી. જયારે ગટેલે એ વાત બહાર પાડી તે વખતે વૈજ્ઞાનિકો ની દુનિયા એટલી હચમચી ઉઠી કે તે વાત ને વૈજ્ઞાનિકો હિલા બૉમ્બ તરીકે જાણે છે. કરોડો ડોલર્સ ના સંશોધનો કૈક જુદું વિચારીને વૈજ્ઞાનિકો કરી રહ્યા હતા તે નકામા થઇ ગયા. હેન્રીએટ્ટા બહેન ના એક કેન્સરે આખા એક દેશની જ નહિ પણ બીજા ઘણા દેશોની લેબોરેટોરી માં પ્રસરીને ઘણી સેલ લાઈન ને દુષિત કરી નાખેલ। આજે પણ વૈજ્ઞાનિકો સંશોધન માટે હિલા સેલ લાઈન નો વપરાશ કરે છે. પરંતુ તેઓ બીજી લાઈન ને દુષિત ન કરે તેનો ખાસ ખ્યાલ રાખે છે. જો હિલ સેલ્સ કોઈ પણ સેલ ને આડકતરી રીતે પણ અડે તો તે તુરંત બીજા સેલ ને દુષિત કરી અને તેનું વર્ચસ્વ જમાવે છે.  આજે પણ  હેન્રીએટ્ટા બહેન ના એટલા હિલા સેલ દુનિયાભર ની લેબોરેટોરી માં છે કે અમુક અનુમાન ના આધારે તેને ભેગા કરીને વજન કરીએ તો તે 500 મિલીઓન મેટ્રિક ટન અથવા 10 એમ્પાયર સ્ટેટ બિલ્ડીંગ જેટલું તેનું વજન થાય. 

રેબેકા સ્કલૂટ કરીને લેખિકાએ આ વાત લખી ત્યારે તેણે હેન્રીએટ્ટા ના કુટુંબ ને મળીને તેમની વાત પણ આ વાર્તા માં વણી લીધી છે. સ્કલૂટ કહે છે કે હેન્રીએટ્ટા નું શરીર ઠંડી જમીન માં દફનાવેલ પડ્યું છે, અને તેનું કુટુંબ ગરીબીમાં ગોથા ખાય છે જયારે હેન્રીએટ્ટા ના હિલા સેલ ને કારણે દુનિયામાં કેન્સર ની જાણકારી માં ઘણી પ્રગતિ થઇ રહી છે. સ્કલૂટ ના કહેવા અનુસાર, આ સંશોધન માંથી નફો કરનાર ફાર્મા કંપની દ્વારા, હેન્રીએટ્ટા ના કુટુંબ ને કૈક હિસ્સો મળવો જોઈએ। રેબેકા ના લખાણ થી હવે આ વાત ની ચર્ચા થઇ રહી છે અને હવે સંશોધન માટે દર્દીઓનું લોહી, થુંક, સેલ વગેરે વપરાય તે માટે પહેલેથી પરવાનગી લેવામાં આવે છે.  જો તમે Kaiser ના મેમ્બર હો તો તમે આવા ફોર્મ સાઈન કર્યા હોય તે તમને યાદ હશે. 

હવે તો બે, ત્રણ પેઢી બાદ હેન્રીએટ્ટા ની નવી પેઢી ભણી ગણી ને હોશિયાર થઇ રહી છે અને તેઓ સ્ટેનફોર્ડ યુનિવર્સિટી વગેરે જગ્યાએ લેક્ચર આપે છે. તેમનું કહેવું છે કે સંશોધન કરનાર વૈજ્ઞાનિકો અને તે વૈજ્ઞાન ની જાણકારી ને આધારે ઉપચાર પામનારા લોકોએ એટલું ધ્યાન માં રાખવું જોઈએ કે આ જાણકારી લોકોના દર્દ માંથી પેદા થઇ છે અને તે લોકોના આપણે ઋણી છીએ. હેન્રીએટ્ટા બહેન ના પૌત્ર પૌત્રીઓની વાત તદ્દન ખરી છે.  આજે તેમને યાદ કરતા આપણે પ્રાર્થના કરીએ કે પ્રભુ હેન્રીએટ્ટા બહેન ના આત્મા ને શાંતિ આપે.

જો તમારા પુત્ર, પુત્રી કે પૌત્ર, પૌત્રીઓ બાયોલોજી ના વિષય માં કામ કરતા હોય તો તેમને હિલા સેલ વિષે જરૂર પૂછશો। તમને અંગ્રેજી વાંચવું પસંદ હોય તો રિબેકા સ્કલૂટ લિખિત ચોપડી નું નામ છે “The Immortal Life of Henrietta Lacks” by Rebecca Skloot. 

 

કવિ ની માળી સાથે વાત (Poet talks to Gardner) – Poem

Reblogging my earlier poem with English translation….

Darshana Varia Nadkarni's Blog

Reblogging my earlier poem with English translation

Poet’s talk with Gardner

Ah your garden’s pretty flowers! My garden grows words
You put flowers in rows, I arrange words in lines
Your seedlings yield pretty flowers and sweet fruits
My words form poetry, ties that bind us to our roots

માળી, તારા જેવો મારો બગીચો, આવ હિંચકે જુલ
ફરક માત્ર એક જ
મારા બગીચા માં ઉગે શબ્દો ના છોડવા, ખીલે શબ્દો ના ફૂલ

તું બીયા ને પાણી પાય ને તારો છોડ મોટો મોટો થાય
ધીમે ધીમે તેમ જ
મારા મગજ માં ઘૂમી રહેલા શબ્દો કવિતા માં બદલાય

તું ખાતર નાખે અને એક દિવસ નાના છોડ નું બને મોટું ઝાડ
વાક્યો ભેગા થાય એમ જ
અને અંતર ની લાગણીઓ પદ માં ગોઠવાય જયારે પાડું હું સાદ

તારી મહેનત ના બદલા માં જયારે આપે ઝાડ મીઠા ફળ
થાય મને તેવો જ રોમાંચ
જયારે પૂરી કવિતા બને અને મારી મહેનત થાય સફળ

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