JOBS – June, 2021


Office, Notes, Notepad, Entrepreneur, Hand, Secretary

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 a&t hot mail or find me on Linkedin.

Senior Director/ VP of Regulatory Affairs – San Jose, CA

The position is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams & will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination products from preclinical candidate designation through product approval, including regulatory submissions. Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) and for covering multiple development projects.

Major Duties and Responsibilities

  • Develop and execute regulatory strategies for earliest possible approvals for development programs.
  • Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
  • Set strategy for submissions of product registration documents to health authorities worldwide. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions.
  • Prepare submissions and regulatory filings of INDs, CTAs, BLAs, NDAs, MAA and other submission documents including meeting packages, briefing documents, responses, supplements etc.
  • Experience in CMC regulatory compliance to ensure CMC practices are carried out in agreement with regulatory agencies requirements and expectations
  • Review clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites.
  • Interact with regulatory agencies on defined matters. Liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests.
  • Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input as applicable.
  • Interface with international affiliates on regional regulatory strategy and implementation of plans.
  • Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
  • Contribute to the development and maintenance the Regulatory Affairs working practices and procedures.

Education and/or Job Experience

  • 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.
  • Ability to travel

PROJECT MANAGER – San Jose, CA

We are seeking an experienced Project Manager to lead the successful execution and launch of engineering projects in a fast-paced environment.  The position has responsibility for daily management of complex projects and requires a high degree of coordination with a cross-functional team including Engineering, Manufacturing, Biology, Quality and Facilities.

Job Requirements

  • Oversee and drive multiple engineering projects of various size and complexity from initiation through validation and production release
  • Responsible for developing realistic project schedules, along with resource planning, risk management and measurable metrics to meet the project goals
  • Communicate progress to stakeholders including the executive leadership team and provide recommendations for mitigating risks or delays 
  • Coordinate interdependent tasks and deliverables with key stakeholders including R&D Engineering, Manufacturing & Process Engineering, Facilities, EH&S, and Quality Assurance
  • Lead and manage team meetings by creating agendas, presentations, minutes and action items. Document team decisions and follow up on action items and deliverables
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation 

Qualifications

  • BS degree in engineering or a related technical field
  • 7-10 years of experience with managing engineering projects and use of standard project management methodology, tools and/or software packages
  • The successful candidate will apply strong people and negotiation skills to plan, coordinate and execute all relevant activities in a phase- gate setting 
  • Excellent interpersonal skills with an ability to communicate to people at all levels of the organization
  • Strong leadership skills, self-motivated and ability to influence others to achieve successful outcomes 
  • The position requires a high degree of adaptability, flexibility, creative decision-making, and technical problem-solving abilities 
  • Excellent verbal, written, presentation and interpersonal skills
  • Must be able to handle multiple projects with exceptional organizational and time management skills
  • Proven experience using Project Management tools to manage complex project timelines as well as fluency with Excel, Word, PowerPoint and Visio 
  • Proven track record with Medical Device, FDA regulations, ISO, cGMP and QMS standards
  • In-depth understanding of verification & validation (IQ,OQ,PQ) as well as risk analysis (FMEA)

Preferred Qualifications

  • PMP certification
  • Experience with Visual Project Management 
  • Experience with turnkey, capital equipment
  • Familiarity with sterilization process and aseptic manufacturing

Travel

Up to 10%

Quality Assurance 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 to support 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.

Responsibilities

Maintain and improve 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.

Requirements

A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device), Experience with FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971), Experience with non-conformances, CAPA, and Risk Management, 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) and BS in Engineering is required. 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 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.

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.

Senior Scientist/ Dir – 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

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.

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 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.

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Guilty – Bollywood Movie Review


“Guilty” is a Hindi Bollywood movie directed by Ruchi Narain and written by Ruchi Narain, Kanika Dhillon and Atika Chohan. Released in 2020, it focuses on the events that transpired at the peak of the #MeToo movement, in 2018. 

Guilty movie review: A lost opportunity | Entertainment News,The Indian  Express

Nanki (Kiara Advani) writes lyrics for a band in which her boyfriend, VJ Pratap Singh (Gurfateh Singh Pirzada) is the lead singer. While the upper class, English speaking hot couple inspire jealousy and admiration from their classmates, Tanu (Akanksha Ranjan Kapoor), a Hindi speaking girl from Dhanbad, who openly hits on VJ, then accuses him of raping her as his friends watched on. The accusation comes via a tweet that leads to a social media storm with appropriate hashtags. 

As is often the case in Indian society, everyone gets involved with half baked partisan opinions and judgments. The college students are divided; with many accusing Tanu for her flirtatious come-ons and revealing clothing, while others stand by her and participate in protests in her defense. Same is true in VJ’s case and he also has support of his politically connected parents, powerful politicians and socialites.

At no point, has the film lost sight of the fact that this is a complex matter. Even as you get manipulated into judging the characters and as the story begins to unravel you change sides several times, you also begin to realize how nuanced gender power issues are. You grapple with issues such as, should a girl be  judged for being flirtatious, accused of inviting unwanted sex; could she have sex with someone she craves and then cry rape; can an upper class young man who has the attention of hottest girl on campus force himself on any other girl, could he have had  consensual sex and then be accused of rape for profit and attention; could these issues be quashed with money and pressure? 

The film focuses on the crucial subject matter, very pertinent in Indian society and it certainly brings forth some key issues into the forefront like this is a subject matter for the society to tackle, instead of putting entire responsibility on women and slut-shaming or blaming women for clothing choices, and treating women with paternalistic condescending advice on how to protect themselves. However, as much of the movie focuses on he said, she said narrative, it does not move the dialog forward with confidence. While it covers the intellectual and moral basis of arguments, it does so with some trepidation, not with authority. 

Despite some of its flaws, Guilty inspires discussion on an extremely pertinent subject, deeply interwoven with culturally prescribed gender roles. I rate the movie 4.2 on a scale of 1 to 5, with 5 being excellent.

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Entrepreneurship was his passion, leadership, his expertise


Entrepreneurship was his passion, leadership, his expertise. Google was a young company when Nikesh Arora chose to join @Google over founding his own company. Under his skilled leadership, the company’s operations grew rapidly and in 2011, Arora became Senior Vice President and Chief Business Officer of Google.  After working in Google for nearly a decade, Arora joined @SoftBank, a Japanese multinational company. Arora guided SoftBank investments in startups like Ola and Grofers and SoftBank grew rapidly. 

Palo Alto Network headquarters exterior under blue sky. Palo Alto Networks, Inc. is a network and enterprise security Palo Alto Network headquarters exterior under blue sky. Palo Alto Networks, Inc. is a network and enterprise security - Santa Clara, CA, USA - 2020 Building Exterior Stock Photo

In 2018, Arora joined Palo Alto Networks and currently serves as the CEO and Chairman of this leading #cybersecurity and cloud computing company. Cyber security experts have to constantly figure out innovative ways to keep up with cyber hackers, who got even more active during Covid 19 pandemic. According to Dzone research, almost 53% of SMB’s suffered from a data breach during 2020.

After Arora joined Palo Alto Networks, under his leadership, the company made the biggest acquisitions in its history with the acquisition of Demisto for $560 million followed by Twislock for $410 M and recently @Aporeto for $150M.  Given the company’s scale compared to smaller competitors in the segmented cybersecurity market, its double digit growth remains solid. PAN leadership has maintained that PAN is still on track to grow revenue by 20% annually until 2022 and its operating free cash flow margins are expected to exceed 22% and 30% respectively. 
Inviting entrepreneurs to take the exciting opportunity to hear Nikesh Arora, CEO of PAN speak at @TiEcon 2021on May 7 at the link  https://www.tiecon.org/register?utm_source=Darshana_Nadkarni&utm_medium=referral&utm_campaign=Volunteer_Contest . At TiEcon, there are exciting #entrepreneurship tracks and other tracks on #CloudComputing #Security #Healthcare and more.

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Pagglait – Bollywood Movie Review


Majority of Bollywood movies used to have a lot of fluff (silly song and dance numbers and silly dialogs to fill up time). But Pagglait movie written and directed by Umesh Bist is a work of genius. Almost everything gives a deep insight into something; there’s family gossip, financial wranglings and machinations, religious dogma and casteist beliefs and rituals, and a recently widowed woman who had not known love in her marriage but was left with more questions and confusion, after the death of her husband. All of this is packed into one story.

Pagglait trailer: Comedy and death combine in Sanya Malhotra's quirky  Netflix film | Entertainment News,The Indian Express

Heroine Sandhya Giri (Sanya Malhotra) is brilliant in her understated emotions and dialogs. She lost her husband Astik Giri soon after their marriage. Sandhya confesses to her friend Nazia (Shruti Sharma) “बचपन में हमारे पास एक बिल्ली थी. कार  के निचे आ गयी. हम बहुत रोए थे यार. वैसा कुछ भी नहीं लग रहा है. रोना भी नहीं आ रहा है. मगर भूख बहोत लगी है”. Sandhya is not even able to pretend to be grief-stricken.

Every character has a well earned place in the film. Sandhya comes to meet her departed husband’s colleague Aakanksha (Sayani Gupta) and an unlikely bond develops between two young women who would have been sworn enemies in most traditional movies. Sandhya’s in-laws and departed Astik’s grief stricken parents (Sheeba Chadha & Ashotosh Rana) find themselves at the mercy of their extended family’s manipulation, in their moment of heartbreak.

Sanya Malhotra’s acting is subtle, yet sharp and the movie is complex, yet focused. The story that begins with the tragic death of a man, leaving his confused wife a young widow, ends with her finding life and reasons to live.  I rate the movie a high 4.9 on a scale of 1 to 5 with 5 being excellent.

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Diversity & Inclusion Data in Netflix Productions


Netflix shares D&I data in its productions

Netflix, Computer, Snacking, Cushion

What has entertainment got to do with diversity and inclusion? Actually plenty. As a Diversity & Inclusion training provider, I was thrilled to see Netflix keeping track and providing D&I data in its productions. Diversity promotes inclusion, appeals to a larger audience, and gives people a chance to learn about different cultures. Recently, the streaming giant Netflix commissioned a study to look at its own 2018 and 2019 productions. The study analyzed 126 movies and 180 series released during 2018 and 2019.

Findings are not only striking and breath-taking but inspirational. The study found that fifty-two percent of Netflix films and series in 2018 and 2019 had girls or women in starring roles and 35.7 percent of all Netflix leads during this time came from underrepresented groups, compared with 28 percent in the top 100 grossing theatrical films. 

An example is #BridgertonOnNetflix that not only casts women and under-represented groups but also tackles race and gender in interesting and contrasting ways. In this period drama series, set in Regency England, a color blind society emerges in sharp contrast to a gender biased one.. Following a wedding between their white king and black queen, the society has achieved true racial equality. On the other hand, gender is left alone. So here, “a wayward touch or heaven forbid a kiss would banish any young lady from a society in a trail of ruin” and yet all the delicate issues pertaining to women’s honor are considered men’s affairs and it then becomes men’s duty to solve these issues, sometimes through deadly duels. Sarcastic wit is both entertaining and illuminating.  My review is at link https://bit.ly/2KbVyzr .

Or consider Never Have I Ever, coming of age drama series. Fifteen year old heroine, Devi Vishwakumar (Maitreyi Ramakrishnan) is an insightful teenager. Stereotypes are tackled with sarcasm. When she tells her therapist that she wants to have sex with a hot kid in the class, in order to join the grownup world, her therapist assures her that he may be hot but he still has problems. To that Devi replies, “Hot people don’t have problems. I have seen people in your waiting room — they are mostly uggos”.  Clever use of sarcasm in another netflix serial, Kim’s Convenience also helps break down stereotypes and stars as Korean family, Paul Sun-Hyung Lee, Jean Yoon, Andrea Bang, and Simu Liu. 

And then there are other films like the movie “Sir”, starring Tilotama Shome & Vivk Gomber. With understated dialogues and masterful use of silences, the movie brings in the forefront crucial issues of class and caste in Indian society. Here is link to my review  https://bit.ly/38NehLe . In Hillbilly Elegy, (link to my review https://bit.ly/3qgHEeR),  light shines on the chief divides in the USA, poverty and its accompanying scourges, social isolation, lack of medical resources, drug use and religious and political divides.  

Movies and serials on Netflix still do have glaring deficiencies in achieving better gender and racial parity. For instance, 96 percent of stories did not have any women onscreen who identify as American Indian/ Native Alaskan, 68.3 percent of the content evaluated did not include a speaking role for a Latina and LGBTQ characters were often marginalized.

Group of children smiling and looking at the camera diversity Group of children smiling and looking at the camera Child Stock Photo

What is interesting however, is that the streaming site is paying close attention to the issues of diversity and inclusion in entertainment and acknowledges the importance of its role in changing things in society.  Netflix’s film chief, Scott Stuber acknowledged its importance and Netflix’s chief executive Ted Sarandos said, “the company is committed to releasing a new report every two years through 2026”. He further said, “our hope is to create a benchmark for ourselves, and more broadly across the industry”.

This is leadership. And I can’t wait to hear Netflix co-founder, chairman and co-Chief Executive Officer, Reed Hastings speak at #TiEcon2021. I hope he will speak to the issue of the importance of diversity and inclusion in entertainment. I hope he will also share how and  in what other ways Netflix is taking this seriously in how it weaves in D&I internally. Register for www.tiecon.org for the virtual tiecon and May 6-8, 2021. With an exemplary lineup of keynotes, speakers and panelists, you will not want to miss the virtual conference. 

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મુગલ રાજ્યની એક અનન્ય રાણી – નૂરજહાં


માર્ચ 8 ના આંતરરાષ્ટ્રીય મહિલા દિવસ નિમિતે ઇતિહાસ માં ડૂબકી મારીને એક એવી સ્ત્રી વિષે જાણકારી મેળવીએ જેણે પોતાના પતિ જોડે હારોહાર રાજ્ય સંભાળ્યું અને તે પણ એવા સમયે જયારે મોટા ભાગની મોગલ પત્નીઓ હેરેમ માં મોજ કરતી અને તેમને બીજી કોઈ સત્તા ઉપલબ્ધ નહોતી. 

Noor Jahan — the legendary Mughal empress — Part II - Daily Times

ઘણીવાર ઇતિહાસ માં સ્ત્રી કરતા પુરુષને વધારે મહત્વ મળ્યું છે. મુમતાઝ મહાલ માટે તાજ મહાલ બનાવી ને શાહ જહાંને તેની રાણી ને અને તે બંને ની પ્રેમ કથાને ઇતિહાસ માં અમર બનાવી દીધી. પણ એક બીજી રાણી જે મુમતાઝ ની ફઈ હતી અને મુમતાઝ ના લગ્ન પછી તે તેની ઓરમાન સાસુ બની તેની અને તેના પ્રેમ ની અને તેની સતા ની વાત કરીએ. 

તે છે નૂરજહાં, શાહજહાં ના પિતા જહાંગીર ની 20 મી પત્ની.  નાનપણ માં અનારકલી જોડે તેનો સબંધ તેના પિતા અકબરે માન્ય ન રાખ્યો પછી (સલીમ) જહાંગીર ની નજર માં આવી બીજી એક સામાન્ય છોકરી, મહેરુનિસ્સા. પણ અકબરને તે પણ માન્ય તો હોય જ નહી ને? તે સમય ની રસમ પ્રમાણે જહાંગીર ના 19 લગ્ન આજુબાજુના મહારાજાઓની જોડે સબંધ કેળવવા માટે કરવામાં આવેલા અને મહેરુનિસ્સા ના લગ્ન પણ થઇ ચૂકેલા. મહેરુનિસ્સાનો પતિ તેને મારપીટ કરતો અને તેમનું લગ્ન જીવન સુખી નહોતું. તેવામાં મહેરુનિસ્સાનો પતિ ગુજરી ગયો. જહાંગીર ના તો 19 લગ્ન થઇ ચૂકેલા અને એ સિવાય તેની નજર પડે તે સ્ત્રી તેના માટે મૉટે ભાગે તેને સ્વીકારવા અને સંતોષવા માટે હાજર હતી. એવા સમયે તેની નજર માં ફરી આવી મહેરુનિસ્સા, એક સામાન્ય સ્ત્રી, એક સામાન્ય સૈનિક ની દીકરી, એક વિધવા સ્ત્રી, એક બાળકી ની મા, તેની નાનપણની પ્રિયતમા, મહેરુનિસ્સા. જહાંગીર મહેરુનિસ્સા ઉપર ફરી ફિદા થઇ ગયો અને બંને વચ્ચે ફરી  ઊંડો પ્રેમ સબંધ બંધાયો. પણ પછી અચાનક મહેરુનિસ્સાએ તેના પ્રેમનો અસ્વીકાર કર્યો અને શરત મૂકી કે જો જહાંગીરને સાચો પ્રેમ હોય તો તે મહેરુનિસ્સા જોડે લગ્ન કરે. લોકો તાજ્જુબ થઇ ગયા અને જહાંગીરને ઘણી શિખામણ મળી કે તે બિલકુલ યોગ્ય નથી. તેમજ મહેરુનિસ્સાને ઘણી શિખામણ મળી કે આવા મોટા મહારાજાએ તેને અપનાવી છે તેને પોતાના નસીબ માની અને જિંદગી જીવી લેવી. જહાંગીરે મહેરુનિસ્સાને કપડાં અને જવેરાત મોકલી ને મનાવવાની કોશિશ કરી પણ મહેરુનિસ્સાએ બધું પાછું મોકલ્યું. છેવટે પ્રેમ માં પડેલ મહારાજાએ ધામધૂમથી મહેરુનિસ્સા જોડે લગ્ન કર્યા અને તેની 20 મી રાણીને નૂર જહાં (દુનિયા ની રોશની) ના નામ થી નવાજી.

નૂરજહાંએ તેના ભાઈ ની દીકરીના લગ્ન જહાંગીર ના દીકરા શાહજહાં જોડે કરાવ્યા.  શાહજહાં ની મા અને જહાંગીર ની પહેલી પત્ની જગત ગોસીની (ગોસેઇન) અને નૂરજહાં વચ્ચે બહુ સારો સબંધ હતો નહિ. નૂરજહાંએ શાહજહાંના અને જગત ગોસીની ગોસેઇન ના દીકરા ના વિવાહ પોતાની ભત્રીજી જોડે કરાવીને પોતાની સત્તા જમાવી લીધી — આ તેની પહેલી ચાલ. શાહજહાં ને મુમતાઝ જોડે પ્રેમ હતો અને અલબત્ત તેણે મુમતાઝ ની યાદ માં તાજ મહાલ બંધાવ્યો. પરંતુ તેના જીવન દરમ્યાન મુમતાઝ તેના છોકરાઓ જણવામાં વ્યસ્ત હતી અને નાની ઉંમરમાં તે બાળજન્મ સમયે મૃત્યુ પામી. પરંતુ તેની ફઈ નૂર જહાં ની વાત અલગ છે. ઇન્દુ સુંદરસેને તેના પુસ્તક, The Twentieth Wife (20મી પત્ની) માં નૂર જહાં ની સત્તા વિષે ઘણી જાણકારી આપી છે. 16 અને 17 મી સદીમાં મુગલ રાજ્ય દુનિયાભર માં તેની શાન અને સંપત્તિ માટે મશહૂર હતું. નૂરજહાં ખુબ બુદ્ધિશાળી સ્ત્રી હતી.  તેના લગ્ન પછી તેની સત્તા વધતી ગઈ. મક્કમ મનની, શક્તિશાળી અને બુદ્ધિશાળી નૂરજહાં માં તેના પતિને પૂરો વિશ્વાસ હતો અને તેના પતિ જહાંગીર કરતા નૂરજહાં વધારે રાજનીતિમાં હોશિયાર હતી. નૂરજહાં ને એટલા હક અને એટલું સન્માન આપવામાં આવતું કે તે કોઈ સ્ત્રીને તે જમાનામાં મળ્યું નથી.  

નૂરજહાં ના નામના સિક્કા બનાવવામાં આવેલા. તે મહારાજની અદાલત માં હંમેશા હાજર રહેતી. ક્યારેક જહાંગીર બીમાર રહે તો નૂરજહાં એકલી અદાલત ભરતી. નૂરજહાં ને શાહી સીલ નો હવાલો જહાંગીરે આપેલો તેથી તે શાહી દસ્તાવેજ અને હુકમો ઉપર કાનૂની સહી કરી શકે. રાજનીતિ ના દરેક મામલામાં જહાંગીર તેના મંતવ્ય નો આગ્રહ રાખતો. અને એક સમયે નૂરજહાં યુદ્ધ માં પણ ઉતરેલી. શાહજહાંને તેના પ્રેમ ના નામથી મુમતાઝ ની યાદ માં તાજ મહેલ બાંધ્યો અને તેને લીધે મુમતાઝ નું નામ ઇતિહાસ માં અમર થઇ ગયું. પણ મુમતાઝે રાજ્યના કામકાજમાં ક્યારેય કોઈ રસ લીધેલો નહિ અને શાહજહાંને ક્યારેય કોઈ બાબત ઉપર તેનો મત પૂછેલો નહિ. જયારે નૂરજહાંએ તેના પતિની હારોહાર ઉભા રહીને, તેની જિંદગીની જીવનસાથી બનીને રહી અને આ રીતે નૂરજહાં મુગલ ઇતિહાસ માં એક અનન્ય સ્ત્રી રહી છે. 

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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.

Home Office, Workstation, Office

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.

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દ્રષ્ટિકોણ: દુર્લભ રોગ (rare diseases)


આજે “રેર ડીઝીસ” ડે ના દિવસે “દુર્લભ રોગ” વિષે વાત કરીએ.  એવા ઘણા દુર્લભ રોગ છે જેને અનાથ રોગ પણ કહેવાય છે, કેમ કે તેના નિવારણ ઉપર ઘણા લોકો કામ કરતા હોતા નથી. દુનિયા માં 6000 થી ઉપર એવા દુર્લભ રોગ છે. કદી જોયા ન હોય એવા વિચિત્ર રોગ ધારણ કરનાર રોગીઓ પણ ક્યારેક વિચિત્ર લાગે અને તાકી તાકીને જોવાની આપણે ભારતીયોને ક્યારેક એવી ટેવ હોય છે. તો આશા છે કે આ બાબત માં થોડું જ્ઞાન મેળવી આપણે આવા રોગ ને અને રોગીઓને ધિક્કાર કે કુતુહલ થી નિહાળવાની બદલે અનુકંપા ની દ્રષ્ટિ થી જોશું.

કઈ પ્રકારના દુર્લભ રોગ હોય છે તેના વિષે થોડી વાત કરીએ. 

* Proteus syndrome (પ્રોટિયસ સિન્ડ્રોમ): આ એવી પ્રકારનો રોગ છે કે તેમાં શરીરમાં રહેલી પેશીઓ (ટિશ્યૂઝ) વધ્યાજ કરે છે. દરેક ને તે જુદી રીતે અસર કરે છે. કોકના હાથ વધ્યા કરે, કોક નો એકજ હાથ વધ્યા કરે અને કોક ના પગ અથવા એકજ પગ વધ્યા કરે અને કોક નું માથું કે શરીર નું બીજું કોઈક અવ્યય વધ્યા કરે. 

* Fibrodysplasia ossificans progressiva (FOP): (ફાઇબરોડિસપ્લેસિયા ઓસિફિકાન્સ પ્રોગ્રેસીવા) ટૂંક માં (FOP) એવો જ એક ભયાનક રોગ છે જે આખી દુનિયામાં લગભગ 2 મિલિયન લોકોને જ છે. તેમાં વ્યક્તિ પોતાના હાડકા ના પિંજરા માં કેદી બની જાય છે. આ રોગ માં હાડકા વિકસતા જાય છે અને વ્યક્તિના હાડપિંજર જોડે જોડાતા જાય છે. ધીમે ધીમે વિકસતા જતા હાડકાની અંદર માણસ ભીંસાતો જાય છે અને ધીમે ધીમે તેની પ્રવૃત્તિ રૂંધાતી જાય છે અને ભીંસાતી વ્યક્તિ પોતાના હાડકામાં રૂંધાઈને મોત ને ભેટે છે.  અમેરિકા માં હેન્રી ઇસ્ટલેક નામના બાળક ને આ રોગ હતો. તે 39 વર્ષે મૃત્યુ પામ્યો ત્યારે તે માત્ર તેની જીભ હલાવી શકતો હતો બાકી બહારના કોઈ પણ અવ્યય ને તે હલાવી શકતો ન હતો. આ રોગ વિષે નીચેના વિડિઓ માં જોઈ શકશો.

* Severe combined immunodeficiency, SCID: (સિવિયર કમબાઇન્ડ ઈમ્યૂનોડેફિશિનઝિ અને ટૂંક માં સ્કીડ) T cells અને B cells ના genetic mutations ને લીધે થાય છે. આ રોગ હોય તે વ્યક્તિમાં કોઈ પણ જંતુઓનો સામનો કરવાની તાકાત હોતી નથી. આવા બાળકોને કોઈ પણ સહાય ન મળે તો તેઓ એક વર્ષ ની અંદર મૃત્યુ પામે છે. પરંતુ મેડિકલ પ્રગતિ ને લીધે હવે તેઓ બબલ ની અંદર રહીને ઉછરી શકે છે અને તેઓને બબલ બેબી તરીકે ઓળખાય છે. ડેવિડ વેટર નામનો છોકરો ઘણા વર્ષ આ રીતે જીવિત રહેલો. તે એવા બબલ ની અંદર જીવિત રહેલ કે તેને ક્યારેય કોઈ અડકી ન શકે અને તે બહારની વસ્તુઓને એકદમ સાફ કાર્ય વગર હાથ લગાવી ન શકે.

* Moebius Syndrome (મોબીયસ સિન્ડ્રોમ): આ રોગ હોય તે લોકો સ્મિત કરી શકતા નથી. તે લોકો ફ્રાઉન પણ નથી કરી શકતા અને આય બ્લિન્ક પણ નથી કરી શકતા. તેઓના ચહેરા ઉપર કોઈ પણ પ્રકારના હાવભાવ વર્તાઈ શકતા નથી. 

*  water allergy or “aquagenic urticaria” : પાણી ની એલર્જી જન્મ થી નથી હોતી પણ યુવાવસ્થામાં ઉત્પન્ન થાય છે. મૉટે ભાગે એક મા બાળક ને જન્મ આપે તે પછી તેને ક્યારેક આ રોગ થાય છે. આજ સુધી માં માત્ર 30 કિસ્સા નોંધાયા છે. તાજેતરમાં ઇંગ્લેન્ડ માં 21 વર્ષની યુવતીને તે રોગ થયો અને ત્યાર બાદ તે બિલકુલ પાણી પી સકતી નથી અને અઠવાડિયામાં એક વાર 10 સેકેન્ડ માં નાહી લ્યે છે નહિ તો તેને આખા શરીરે ખુબ બળતરા અને રાશ થાય છે. તે માત્ર ડાઈટ કોક પી શકે છે. 

* Guillain-Barre syndrome (ગીયાનબારે સિન્ડ્રોમ): આ રોગ અચાનક જ શરીરમાં આવે છે.  શરીર ની ઇમ્યુન સિસ્ટમ જે બહાર ના રોગી જંતુઓનો સામનો કરે છે તે સિસ્ટમ આ રોગ માં પોતાના શરીર નો સામનો કરવા માંડે છે. એકદમ જલ્દી ફેલાતા આ રોગ માં વ્યક્તિ પેરાલાઇસ પણ થઇ શકે છે. આ રોગ થી વ્યક્તિને બોલવા, ચાલવા, ખાવા, પીવા, બાથરૂમ જવામાં અડવડતા થાય છે. જેવી ઝડપ થી આ રોગ આવે છે અને ફેલાઈ છે તેવીજ ઝડપ થી ક્યારેક આ રોગ ચાલ્યો જાય છે અને ક્યા કારણ થી આ રોગ આવે છે તેની મેડિકલ વિભાગ માં પુરી જાણકારી નથી. મારા બે મિત્રોને આ રોગ થયેલો અને બંને હવે સારું સ્વાસ્થ્ય ધરાવે છે.  કોઈપણ વ્યક્તિને ક્યારે પણ આ રોગ થયો હોય તેમણે કોઈપણ વેક્સીન અને અત્યારે કોવીડ વેક્સીન  લેતા સમયે ડોક્ટર ના અવલોકન હેઠળ લેવાનું જરૂરી છે.

તો આ દુર્લભ રોગ દિવસ શા માટે છે અને આજે આપણે શા માટે તેના વિષે વાત કરી રહ્યા છીએ?

દુનિયા માં આવા 6000 જેટલા રોગ છે. અમેરિકામાં 2 લાખ થી ઓછા લોકોને આવા રોગ થાય છે. તેથી ભાગ્યેજ કોઈ કંપની કે વૈજ્ઞાનિક તેનું નિવારણ શોધવા માટે કામ કરતા. કેમ કે આવા રોગો આટલા દુર્લભ હોય તો તેઓ તેના નિવારણ ઉપર વર્ષો કામ કરે અને તેની કયોર શોધે તે પછી તેમાં તેમને શું વળતર મળે? અને તેવીજ રીતે આવા દુર્લભ રોગો નો સામનો કરનાર વ્યક્તિ પણ ખુબ એકલતા અનુભવે છે અને તેમને મિસ ડાયગ્નોસિસ અને લોકોના પૂર્વગ્રહ નો સામનો કરવો પડે છે. પણ હવે આવા દુર્લભ રોગોને સમજવા માં ઘણી પ્રગતિ થઇ રહી છે. દુર્લભ રોગ દિવસ નો હેતુ લોકોમાં, સમાજમાં, મેડિકલ વિભાગોમાં અને નીતિ વિભાગોમાં તેના વિષે જાણકારી અને સમજણ વધારવા માટે નો છે. તેમજ હવે જેમને આવા દુર્લભ રોગ હોય તેઓના જૂથ બન્યા છે અને તેઓ એકબીજા જોડે નવી શોધ થાય તેની આપ લે કરે છે. 

નવા માર્ગદર્શન અનુસાર FDA પણ દુર્લભ રોગો (જેના બે લાખ થી ઓછા કિસ્સા અમેરિકામાં નોંધાયા હોય), જેના ઉપર વૈજ્ઞાનિકો કામ કરી રહ્યા હોય તેઓના માર્ગ માંથી વિઘ્નો હટાવી અને તેમને દરેક રીતે અનુકૂળતા મળે તે માટે સહાય કરી રહ્યા છે. હવે આવા રોગ ના નિવારણ ઉપર ઘણા વૈજ્ઞાનિકો અને નાની નાની  કંપની હવે કામ કરી રહી છે. 

ભારત માં ઉછરતા મને ખ્યાલ આવ્યો નહિ કે જુદા દેખાતા લોકોને તાકી તાકી ને જોવાની કેવી આદત આપણા ભારતીઓમાં હોય છે. પણ દર વર્ષે હું મારી દીકરી ને લઈને ભારત જતી અને તે હંમેશ મને કહેતી કે — મમ્મી અહીં બધા હંમેશા આપણી સામે તાકી તાકીને કેમ  જોવે છે?  મારી દીકરી ના પહેરવેશ અને વાતો પરથી તુરંત બધા સમજી જતા કે આ વિદેશ થી આવેલ લાગે છે. અને એક થોડું પણ જુદું માણસ દેખાય તો લોકો ટગર ટગર જોવા લાગે. હવે તે બાબતમાં હું પણ સંવેદનશીલ થઇ ગઈ છું. બે વર્ષ પહેલા હું એકલી દિલ્લી થી અમૃતસર જવા નીકળી. ટ્રેન માં હું મારી ચોપડી વાંચતી હતી. અચાનક મેં ઉપર જોયું તો આજુ બાજુ બેઠેલા ચાર પુરુષો મારી સામે તાકી ને જોઈ રહ્યા હતા. આ રીતે વ્યક્તિને આપણે સંકોચ અનુભવતા કરી દઈએ છીએ.  તો આવી જાણકારી મેળવીને આશા છે કે આપણે કોઈને તાકી ને જોવા ની બદલે તેમની જોડે મૈત્રીભાવ કેળવી શકીએ.  

નીચેના વિડિઓ માં દસ બીજા દુર્લભ રોગ વિષે જાણકારી મેળવી શકશો. https://www.youtube.com/watch?v=SsGA_u1ihNs

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Story of innovation, scale, riches & ethics


Ratan N Tata

This man once said “Take the stones that people throw at you and use them to build a monument” and what a monument he built and scaled. He is Ratan Naval Tata, scion of the Tata family and great-grandson of Jamsetji Tata, the founder of Tata Group. First, what is Tata Group?

Tata Group is one of the biggest and oldest industrial groups in India. Under the leadership of JRD Tata in 1938, Tata Group assets grew quickly from USD $ 101 Million to over USD $5 billion. Tata Sons further grew the conglomerate of 95 enterprises with vertical and horizontal expansion into sectors such as steel, chemicals, technology, cosmetics, marketing, engineering, manufacturing, tea, software services and more. 

At a certain point, the company looked like it was headed to collapse. Rata Tata became chairman of the Tata Group in 1991, the year of economic liberalization in India. True to the adage he lived by, Ratan Tata decided to take advantage of the opportunity. Economy was opening to foreign markets and Tata Group began to acquire a number of companies, including Tetley, Corus Group, and Jaguar and Land Rover. With these acquisitions, under his leadership, Tata Group grew from a largely India centrist organization into a global business of international reputation and standing. The company now works across six continents in over 100 nations, including markets like luxurious vehicles and accessories to opulent five star hotels. “It is not wrong to make money, but it has to be done ethically”, says Ratan Tata.

Take the opportunity to listen to Ratan Naval Tata speak in conversation with Kanwal Rekhi, Managing Director of Inventus Capital Partners at virtual #TiEcon @TiEcon on May 6th. Register with link

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Sir – Movie Review


Writer/ Director Rohena Gera’s Hindi, English and Marathi language movie “Sir” was released at Cannes Film Festival and at New York Indian Film Festival in 2019 and is released in theaters in November, 2020. 

Sir movie review: A courageous traverse into difficult territory |  Entertainment News,The Indian Express

Movie centers around Ratna (Tilotama Shome) who got married and widowed at a very young age and her circumstances boxed her inside a life void of dreams. However, in the hope of saving money in feeding an idle mouth, her family from the village allowed her to work as a maid in Mumbai. This allowed Ratna to both nurse her dreams as well as save money to help her younger sister complete her education. Ratna herself hopes to be a fashion designer. 

Ratna works as a domestic worker in the home of Ashwin (Vivek Gomber) who has recently returned from the USA, after the untimely death of his younger brother. Ashwin’s guests rarely see beyond Ratna’s status, though Ashwin is a kind man. Ratna may not be highly educated and may not be very articulate in her speech. But Ratna has pride, resilience and persistence that can generate respect in anyone, if only they see beyond her status and class. 

Here is a brief dialog between Ashwin and his friend that is rather ordinary from one angle and also extraordinary from a different viewpoint.

Friend: she is your maid
Ashwin: Put that aside for a minute
Friend: How? How can you put that aside?

I won’t say more about the film although there also isn’t much in the plot or the storyline to give away.  The beauty of the film lies in the masterful use of silence and understated dialogues between people divided by uncrossable red lines, considered sacred by the society. Equally understated ending is at the same time beautiful and brilliant. While to some extent, it may be up to luck and only time may tell what fruits are borne by romance and love, enabling someone to do better, to help them fulfill their dreams, to assist them in upgrading their status, is an undisputed act of love.

Sir movie is streaming on @Netflix and on a scale of 1 to 5 with 5 being excellent, I rate the movie 4.4.

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