Darshana V. Nadkarni, Ph.D.

Recruitment for Biotech & Medical Device companies Training & Consulting in Diversity and Inclusion

Homepage: https://darshanavnadkarni.wordpress.com

Language Archive – Play Review


“What is death to a language.  There are 6900 languages in the world,  Every two weeks, a language dies. This statistic moves me more than any other.  It is death of imagination”. This dialog from Theatrework’s Tony Award-winning “Language Archive” is a celebration of the power of words. And the play itself is also a heart touching rendition of the limitation of language because after all, love transcends words.

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Above everything else, playwright Julia Cho’s quirky sentimental comedy is a celebration of human spirit, with all its tenacity and vulnerabilities. Superbly directed by Jeffrey Lo, every dialog in the play is Muni-Muni (means makes on think deeply in Philippine language). The play centers around whimsical brilliant linguist George (Jomar Tagatac). George’s affirming love for the spoken word and his deep inner struggle to verbalize his innermost feelings are contradictions that point to a larger conundrum – what is more important and more fully defines humans, words or feelings. Even as George devotedly works to preserve and record dying languages of the world, internally he struggles to communicate his feelings to his beloved wife, Mary (Elena Wright). Mary on the other hand, lives in the world of feelings, wears her heart on her sleeve, composes and leaves littler verses for George to find, and cries at the drop of a hat. She is critical of George’s lack of emotions. When George insists that he feels and feels deeply and that his work is devoted to preserving languages and he also deeply mourns the death of a language, Mary counters, “You mourn ideas, not people”.  Mary, a woman of feelings, speaks some of the most memorable lines, including telling George, “There is a certain language, our language, and if you don’t come back, I can’t speak it any more,” and when George does go back, Mary indeed fails to understand him. Emma (Adrienne Kaori Walters) works with George and she understands George more deeply.  She also secretly loves George and pines for him.

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Alta (Emily Kuroda) and Resten (Francis Jue) are endearing old couple who are amongst the last people to speak their native language. However, they only speak in their tongue when they are speaking with love. When they are fighting or sniping at each other, they choose to do that in English. George and Emma are keen to record their language but end up terribly frustrated as Alta and Resten are fighting and refuse to speak in their native tongue, as they snipe at each other in English.  In many ways, it makes intuitive sense that they speak in their native language only when they are communicating deep innermost feelings. After all, language of love is the language of the heart and it supercedes the language acquired through learning of words. Language of love is acquired in infancy, long before an infant learns words. The play beautifully weaves together the amazing power of love beyond words with the power inherent in words that give human feelings of love, longing, fear and vulnerabilities, meaning and substance and enables people engaged in a deep relationship an ability to create their own language.

This is a not-to-miss play of this theater season in the bay area and will be running till August 4 at Lucie Stern Theater in Palo Alto, CA.  Tickets are available at www.theatreworks.org .

Language Archive, Play, Review Julia Cho, Jeffrey Lo, Jomar Tagatac, Elena Wright, Adrienne Kaori Walters, Emily Kuroda, Francis Jue, Lucie Stern Theater, Palo Alto, www.theatreworks.org 

PS: World’s oldest continually operating library where lost languages have been found
archaeology-world.com/this-is-the-wo…

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Response to Tom Friedman (NY Times) – We need outrage, No that is not going to get Trump re-elected.


This is in response to Thomas Friedman’s column “Trump’s Going to Get Re-elected, Isn’t He? Voters have reason to worry”, published on July 16, 2019 in New York Times. .With all due respect “Sir, you are wrong”. With your prescribed cerebral approach to keeping the eye on the prize to winning elections, asking for money when Trump tweets, IS NOT GOING TO HELP DEMOCRATS WIN, not to mention it further corrodes the moral soul of the country.

No, we are not seeking revolution AND yes, we want to beat Trump at the polls. But expressing immense OUTRAGE isn’t exactly revolution. IF we don’t express outrage and let it be our new normal, IF we don’t stand steadfast with our black and brown people and with LGBTQ and with women, then what sir are we going to be able to do for the country? IF a 3 year old Sophie is going to be given a choice between her two parents and we simply collect money to beat these people at the polls, than what about our moral soul, how is our party different from the other party?

But since you want to focus on practicalities and not sentimentalities, then let us do that for a moment. 1) Just as Donald Trump is energizing his base with his relentless racist and sexist tweets, there is a whole Democrat base looking to have their opposition to blatant racism and sexim channled though a leader who can take Trump on. Money is a natural outcome of an energized base. 2) How large is Trump’s base? For the most part, his approval has hovered around 44% and disapproval has hovered around 51%. Do you want to sacrifice or water down the 51% of those looking to beat Trump in order to win a few swing voters? Well sir, those swing voters are right now few or non-existent. People have made up their minds and his base may get more obstinate but will never grow. The country is divided into people who feel morally outraged and those who are enchanted by moral liquidation coming from the highest office in our country. 

Right now, those of us who are outraged that such an individual who got there with outside help is allowed to use his office to incite racism and sexism, are banging our heads in frustration. No, perhaps #impeachment is not an answer because we need to go there only when we have certainty to win. But expressing our outrage in every other way, we ought to do; standing together with our citizens under attack, we ought to do. And even if we don’t take steps to impeach Trump, we need to get every one of his minions who have violated rules and regulations and hatch acts and plaster them all with criminal indictments. We need to blend our forward looking agenda about infrastructure, job creation, minimum pay raise, treating refugees with dignity, with hard issues of border protection, opioid flooding by big pharma and interference into our elections by foreign actors.  These are not simple issues, but to win, we will need to balance complex issues with both firmness and humanity.  No sir, don’t tell us that all we can do is send in money. All our frustrations cannot be culminated into sterile act of writing a check. We need outrage and a leader who will not stoop low to Trump’s level and yet will not balk at standing steadfast against everything wrong that is going on. Right now, we have 20+ awesome individuals who have taken on the challenge to beat Trump and as long as they are not afraid of taking on Trump and of being heard, we will win the election.

You are wrong, because sir, the way to beat Trump at polls is to not let him steal our voice.

 

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JOBS: July, 2019


Good deal. Close-up of two business people shaking hands while sitting at the working place

Please see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience. If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail or find me on Linkedin.

Clinical Trials Manager – San Jose, CA

There is an immediate opening for Clinical Trial Manager to join a high-performance team. The Clinical Trial Manager will be accountable for the day-to-day operational oversight of one or more clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity typically is coordinated in conjunction with one or more CROs. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

Major Duties and Responsibilities

  • Manage the operational aspects of clinical trials
  • Participate in protocol, CRF development, Clinical Study Report preparation, as appropriate
  • Prepare metrics and updates for management, as assigned
  • Proactively identify potential study issues/risks and recommends/implements solutions
  • Participate in and facilitate CRO/vendor selection process for outsourced activities
  • Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
  • May work with CRO to develop and revise the scope of service agreements, budgets, plans, and detailed timelines, and ensure that performance expectations are met
  • Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
  • Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Serve as a liaison and resource for investigational sites
  • Review site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments

Skills

  • Good written and verbal communication skills and proven ability to multitask. Efficient time management and organizational skills. Attention to detail and accuracy in work.
  • Performs job duties with minimal guidance from supervisor
  • Organizes and prioritizes numerous tasks and completes them under time constraints.
  • Demonstrated success in problem solving.
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Ability to constructively interact directly with clinical site personnel

Education and Experience

  • BA/BS or equivalent degree in scientific discipline.
  • Minimum 5 years of clinical trial management experience in biotech
  • Experience in managing outside vendors, e.g., CROs and other vendors
  • Experience with U.S. and Ex-U.S clinical trial management and Regulatory processes

Director of Regulatory Affairs – San Jose, CA

The position is 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.

Major 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.
  • Prepare submissions and regulatory filings of INDs, CTAs, BLAs, NDAs, MAA, 510(k) and other submission documents including meeting packages, briefing documents, responses, supplements etc.
  • 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 plans.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
  • Contribute to the development and maintenance the Regulatory Affairs working practices and procedures.

Skills

  • 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.

Education and Experience

  • Bachelor’s or Master’s degree in scientific discipline required.
  • 10-15 years’ experience in Regulatory Affairs in pharmaceutical, biotechnology or device industry.
  • Thorough knowledge of the drug, device and combination product development process with demonstrated experience in preparing global regulatory submissions.
  • Experience in multiple phases of development in various therapeutic areas.

Senior Quality Engineer – 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.Responsibilities

  • 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: IQC, in-process and finished product testing and product release, Risk Management (FMEA, hazard analysis), internal and external audits and 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
  • Manage the Non-conforming Materials Review (NCMR) in collaboration with Operations to ensure timely reporting, analysis, and resolution of non-conforming material/ product incidences
  • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
  • Address systemic quality issues with suppliers or internal groups
  • Oversee calibration and preventive maintenance program
  • Oversee receiving inspection. Establish and implement systems to ensure timely quality inspections for incoming materials, components or finished goods Identify and report nonconforming material
  • Perform/manage 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
  • The position has supervisory responsibilities for a team of 5-8 direct reports
  • Other duties/ activities may be necessary to support departmental or company goals

Education and/or Job Experience

  • A Minimum of 10 years quality assurance/engineering experience is Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is required
  • BS degree in Engineering is required
  • A Minimum of 3 years’ experience supervising employees
  • 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

Skills and Specifications

  • Ability to motivate and influence people
  • Must possess the ability to handle multiple tasks with high attention to detail
  • Organizing, planning, and problem-solving skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
  • Ability to create and provide training
  • Good statistical and numerical ability

Manufacturing Engineer – San Jose, CA

Summary: Supports the manufacturing of high volume disposable device. Works with engineering and clinical to make sure device specifications conform to device requirements. Works with assemblers and technicians to make sure devices are built to desired specifications.

Responsibilities

  • Evaluate manufacturing processes by designing and conducting research; apply knowledge of product design, fabrication, assembly, tooling, and materials; solicit observations from operators.
  • Evaluate manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
  • Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
  • Assure product and process quality by designing test methods; establishing standards; testing finished product and process capabilities.
  • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
  • Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
  • Work with Development Engineers to effectively transfer new products to Manufacturing.
  • Maintain product and process data.
  • Complete design and development projects by training and guiding technicians and assemblers.

Requirements:

  • Proficient in process validations and its execution
  • Contribute to team effort by accomplishing related results as needed.

Education and/or Job Experience

  • Bachelor’s Degree in Engineering Field or equivalent
  • Minimum 15 years in Medical Device Industry

Skills and Specifications

  • A proven track record with Medical Device Manufacturing Methods and Procedures and FDA QSR 21 CFR Part 820 and ISO 13485 Quality Systems
  • Capable of generating parts, assemblies and drawings using Solidworks
  • Comfortable dealing with complexity and flexibility
  • Experience working under Change Control policies of FDA regulated devices and /or drugs.
  • Ability to proactively identify and solve manufacturing issues.

Senior Manufacturing Equipment Engineer – San Jose, CA

Summary: Supports the manufacturing equipment and tooling used to manufacture company’s proprietary high volume disposable device. Works with Calibration and Preventive Maintenance personnel to ensure equipment is kept in optimal conditions. Works with equipment suppliers/vendors to purchase equipment/parts under our or equipment specifications.

Responsibilities

  • Assures that equipment integration projects are performed under the required timelines and budgets.
  • Develops manufacturing equipment by designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling, and materials; soliciting observations from operators.
  • Identify Capacity and Quality Issues with Manufacturing Equipment. Recommend and Implement Solutions to revolve issue.
  • Provides support and oversees maintenance on Production Molding Machines
  • Design and fabricate of tools and fixtures with In house Machine Shop Equipment
  • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer’s instructions and established procedures.
  • Proficient in developing IQ/OQ/PQ documentation and its execution
  • Maintains product and company reputation by complying with government regulations.
  • Contributes to team effort by accomplishing related results as needed.

Education and/or Job Experience

  • Bachelor Degree in Engineering Field or equivalent
  • Minimum 15 years in Medical Device Industry
  • Experience in plastic molding and material analysis

Skills and Specifications

  • A proven track record with Medical Device Manufacturing Methods and Procedures and FDA QSR 21 CFR Part 820 and ISO 13485 Quality Systems
  • Capable of generating parts, assemblies, and drawings using Solidworks
  • Comfortable dealing with complexity and flexibility
  • Experience working under Change Control policies of FDA regulated devices and /or drugs.

Business AnalystPleasanton, CA

Requires 2+ years experience. Company offers 100% healthcare coverage & other benefits like 401K and there is potential for bonus.

Associate Scientist – Pleasanton, CA
Requires 10+ years pharma R&D experience with expertise in cell biology and should be able to translate it into business. Must know industry well and have a good network.

Director of Pilot Manufacturing – San Jose, CA

Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing. This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.

Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.

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Ashadh ka ek din (on Kalidasa): Naatak Play Review


Ashadh ka ek din (on Kalidas) : Naatak Play Review – June, 2019

Found on principles of bringing on stage intelligent and entertaining shows pertaining to East Asian literature and arts in San Francisco bay area, Naatak has consistently surpassed expectations from a demanding audience.

In Naatak’s 69th production, writer Mohan Rakesh’s “Ashadh ka ek din”, the focus is on young love, simple and lyrical as a poem, pure and unspoilt as nature, passionate and brimming with hope as the drop of first rain, in the month of ashadh. It depicts the story of Kalidasa, classical Sanskrit writer and poet who is presumed to have created his works in the 4th century, and was a royal poet during the reigns of kings Chandragupta II and Yasodharman. Kudos to Naatak for fantastic staging. How they manage it, despite low ticket prices is a mystery. 

It is as true today as it was then that stupendous achievements often come from heart-wrenching personal sacrifices. Kalidas (Anush Moorthy) was ahead of his times and his talents went unnoticed, in his little village. However the king in Ujjain was impressed by his work and sent him royal invitation to go to the capital, Ujjain and adorn the royal court as a national poet. Kalidas is reluctant to leave his beloved, Mallika (Preeti Bhat) who is the inspiration behind many of his works. But Mallika insists that he should not pass up this opportunity which will help bloom his talent.

Kalidas: nayi bhumi sukhi bhi to ho sakto hai

Mallika: koi bhumi aisi nahi jiske antar me komalta na ho, tumhari pratibha us komalta ka sparsh awashya pa legi.

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At the insistence of Mallika, Kalidas leaves his village, not to return for several years. With the force of royal sponsorship, Kalidas writes many epics like medghdootam, kumarsambhawa and raghuwans, all the while his beloved Mallika continues to be his muse. While Mallika pines for Kalidasa in the village. Mallika’s mother Ambika (Anshu Johri) curses Kalidasa and refuses to be drawn into the flow of emotions that have gripped her young daughter.  

Ambika: “ma ka jivan bhavna nahi, karm hai”.

Behind every successful man, there is a great sacrifice of a woman (of course, in the present times, opposite is also true). Produced by Alka Sippy and directed by brilliant, Manish Sabu, “ashadh ka ek din” is a story of love that is eternal, of time which stops for noone, and of sacrifice from which are born great works of art. One thing the play is not and I would have loved more of is Kalidasa’s work itself. The play does not focus as much on his poetry. Kalidasa had written Rutusamhara before he went to Ujjain. If the play included many lyrics from there which spoke of the beauty of the mountains, clouds and rains that appeared even more beautiful to the poet, in the company of his beloved, then it would have enhanced our joy. Nonetheless, it is a tender love story, with beautiful prose and heart-touching dialogues.

 

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JOBS: June, 2019


Image result for jobsPlease see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail or find me on Linkedin.

Manufacturing Engineer – San Jose, CA

Summary: Supports the manufacturing of high volume disposable device. Works with engineering and clinical to make sure device specifications conform to device requirements. Works with assemblers and technicians to make sure devices are built to desired specifications.

Responsibilities

  • Evaluate manufacturing processes by designing and conducting research; apply knowledge of product design, fabrication, assembly, tooling, and materials; solicit observations from operators.
  • Evaluate manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
  • Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
  • Assure product and process quality by designing test methods; establishing standards; testing finished product and process capabilities.
  • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
  • Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
  • Work with Development Engineers to effectively transfer new products to Manufacturing.
  • Maintain product and process data.
  • Complete design and development projects by training and guiding technicians and assemblers.

Requirements:

  • Proficient in process validations and its execution
  • Contribute to team effort by accomplishing related results as needed.

Education and/or Job Experience

  • Bachelor’s Degree in Engineering Field or equivalent
  • Minimum 15 years in Medical Device Industry

Skills and Specifications

  • A proven track record with Medical Device Manufacturing Methods and Procedures and FDA QSR 21 CFR Part 820 and ISO 13485 Quality Systems
  • Capable of generating parts, assemblies and drawings using Solidworks
  • Comfortable dealing with complexity and flexibility
  • Experience working under Change Control policies of FDA regulated devices and /or drugs.
  • Ability to proactively identify and solve manufacturing issues.

Senior Manufacturing Equipment Engineer – San Jose, CA

Summary: Supports the manufacturing equipment and tooling used to manufacture company’s proprietary high volume disposable device. Works with Calibration and Preventive Maintenance personnel to ensure equipment is kept in optimal conditions. Works with equipment suppliers/vendors to purchase equipment/parts under our or equipment specifications.

Responsibilities

  • Assures that equipment integration projects are performed under the required timelines and budgets.
  • Develops manufacturing equipment by designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling, and materials; soliciting observations from operators.
  • Identify Capacity and Quality Issues with Manufacturing Equipment. Recommend and Implement Solutions to revolve issue.
  • Provides support and oversees maintenance on Production Molding Machines
  • Design and fabricate of tools and fixtures with In house Machine Shop Equipment
  • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer’s instructions and established procedures.
  • Proficient in developing IQ/OQ/PQ documentation and its execution
  • Maintains product and company reputation by complying with government regulations.
  • Contributes to team effort by accomplishing related results as needed.

Education and/or Job Experience

  • Bachelor Degree in Engineering Field or equivalent
  • Minimum 15 years in Medical Device Industry
  • Experience in plastic molding and material analysis

Skills and Specifications

  • A proven track record with Medical Device Manufacturing Methods and Procedures and FDA QSR 21 CFR Part 820 and ISO 13485 Quality Systems
  • Capable of generating parts, assemblies, and drawings using Solidworks
  • Comfortable dealing with complexity and flexibility
  • Experience working under Change Control policies of FDA regulated devices and /or drugs.

 

Business Analyst – Pleasanton, CA
Requires 2+ years experience. Company offers 100% healthcare coverage & other benefits like 401K and there is potential for bonus.

Associate Scientist  – Pleasanton, CA
Requires 10+ years pharma R&D experience with 
expertise in cell biology and should be able to translate it into business. Must know industry well and have a good network. 

Regulatory Manager – San Jose, CA
Requires 8+ years of experience in pharma, ideally experience in biologics.

Clinical Trial Manager – San Jose, CA
Ideal experience: 8+ years experience in medical devices, ideal in neuromodulation,  running clinical trials, working with clinicians and medical centers.

Clinical Trial Manager – San Jose, CA
Ideal experience – 8+ years of hands on experience in running pharma trials at manager level. Running clinical studies in biologics is a major plus.

Director of Manufacturing Automation – San Jose, CA

This position requires a dynamic, energetic, self-driven, engineering leader with broad manufacturing engineering and automation experience & will report to VP of Manufacturing Operations. The Director of Manufacturing Automation will lead the development of fully automated manufacturing systems for all aspects of company’s disposable drug tablet manufacturing. This individual will be responsible for defining system requirements, developing proof of principle systems, developing timelines and managing budgets and providing direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. This individual will work closely with product development, manufacturing engineering and quality in order to ensure manufacturability, achievement of targets, and develop processes for optimum manufacturability.

Responsibilities: Define functional & detailed requirements & specifications for manu automation, including quality & regulatory requirements; Manage internal & external process automation programs, project schedules & budgets; Develop facility plans & specifications for manufacturing scale-up; Oversee installation & qualification of automated manu systems; Comply with USFDA cGMP regulations, (ISO), Company policies, operating procedures, processes & task assignments.

Requirements: Experience managing and leading complex cross functional projects involving, electrical, mechanical, quality aspects; Experience with mechatronics or automation engineering including machine, mechanism and fixture design; Strong problem solving and analytical skills; experience with use of statistical analysis & design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation. This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome.  BS/MS in Mechanical, Electrical or Industrial Engineering & 15+ years’ experience managing an engineering group responsible for medical device development and manufacturing engineering with a strong history of hands-on experience is required. Also required Deep expertise in manufacturing automation for large scale manufacturing.

Director of Pilot Manufacturing – San Jose, CA

Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing.  This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.

Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.

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De De Pyar De – Bollywood Movie Review


In Akiv Ali’s Bollywood film, “De De Pyar De”, finally we have a chick flick for men. Fret not; you will see the reason behind this oxymoron very soon.  Movie starts off as a romantic sex comedy between 50 something calm and confident alpha man, Ashish (Ajay Devgn) and about half his age hottie, Ayesha (Rakul Preet Singh). Ashish and Ayesha confidently flirt with each other, then fall in love, and then briefly discuss that gossipers in the community will judge that she is into him for his bottomless wealth (he is an investor in London) and he is into her for her youth and beauty (yes, she is hot) and thus the issue is put to rest.

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Lest we still become judgmental, their flirty tête-à-tête includes sweet caring (she makes dal for him, he says he does not like dal so as to not hurt her feelings) that indicates they are truly into each other and despite deciding to stay away from one another, they just could not. Singh is sexy but also expressive and caring. But that’s not where the film ends with 50 something guy romping with a young hottie. That is just the beginning. The movie wants us to give a stamp of moral approval on this relationship. And that is where the film takes a turn from romantic comedy to family drama. Ashish takes Ayesha from London to India to meet his ex wife and kids and parents.

The problem is —- ok there are many problems that can’t but make us feel a tad judgmental.  First of all, the problem is the girl. She drinks hard, parties hard, doesn’t blink an eye when she passes out and finds herself (undressed) in the morning, in a man’s house. In fact, she is incredulous (perhaps also mildly disappointed) that he passed up on rape and did not take advantage of her. While it is supposed to make the audience look with awe at Devgn’s character, one wonders about Singh’s character and her lack of readiness for a serious relationship with a man with a past. Then the problem is the boy. He does no planning and shows no confidence in any of his past or present relationship decisions and they are all marked by irresponsibility, half truths, hypocrisy and deceit. He takes a girl the age of his daughter to India, without adequately preparing everyone, embarrassing them all.

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The beauty of the movie that makes it all worthwhile emerges in the few short scenes with Tabu (Ashish’s ex-wife). I am sure her dialogs touch the heart of every woman, when she speaks of being tired of always having to be the responsible one and mend relationships. Tabu as a mature mom who listens to all sides and resolves key issues with her daughter’s in-laws, the glue that keeps the family together, admonishing her kids when they get bratty are all beautiful knockout scenes. But it is Tabu’s short speech to her family to stop being judgmental and take responsibility for their decisions, asking them to stop blaming her ex-husband, is phenomenal.  And finally, Tabu’s dialog with Ayesha, her rival for her ex’s attentions, is an absolute gem; although one wonders how realistic it is to expect a wife who is still into her husband, to be so very generous and understanding and go out of her way literally, to bring them together; especially a husband who has been so irresponsible and his girl-friend who is simply too young to grasp all the complexities of a blended family with children her age. But in this movie, after a few speeches, such familial complexities are quickly and conveniently resolved, so Ashish can have his cake and eat it too, without any repercussions. So here it is, finally a chick flick for guys.

De De Pyaar De reviews

If you are willing to ignore complex realities of stormy, messy relationships, simplistic moralizing, and long term lack of wisdom of the characters, overall the film is entertaining and fun.  Tabu and Singh both put on stellar acts. I rate the movie 3.2 on a scale of 1 to 5 (with 5 being excellent).

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JOBS: May, 2019


Please see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail dot com.

Job Search Human Resources Recruitment Career ConceptRegulatory Manager – San Jose, CA
Requires 8+ years of experience in pharma, ideally experience in biologics.

Clinical Trial Manager – San Jose, CA
Ideal experience: 8+ years experience in medical devices, ideal in neuromodulation,  running clinical trials, working with clinicians and medical centers.

Clinical Trial Manager – San Jose, CA
Ideal experience – 8+ years of hands on experience in running pharma trials at manager level. Running clinical studies in biologics is a major plus.

Manufacturing Engineer – San Jose, CA
Requires 8+ years of experience in medical device manufacturing.

Director of Manufacturing Automation – San Jose, CA

This position requires a dynamic, energetic, self-driven, engineering leader with broad manufacturing engineering and automation experience & will report to VP of Manufacturing Operations. The Director of Manufacturing Automation will lead the development of fully automated manufacturing systems for all aspects of company’s disposable drug tablet manufacturing. This individual will be responsible for defining system requirements, developing proof of principle systems, developing timelines and managing budgets and providing direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. This individual will work closely with product development, manufacturing engineering and quality in order to ensure manufacturability, achievement of targets, and develop processes for optimum manufacturability.

Responsibilities: Define functional & detailed requirements & specifications for manu automation, including quality & regulatory requirements; Manage internal & external process automation programs, project schedules & budgets; Develop facility plans & specifications for manufacturing scale-up; Oversee installation & qualification of automated manu systems; Comply with USFDA cGMP regulations, (ISO), Company policies, operating procedures, processes & task assignments.

Requirements: Experience managing and leading complex cross functional projects involving, electrical, mechanical, quality aspects; Experience with mechatronics or automation engineering including machine, mechanism and fixture design; Strong problem solving and analytical skills; experience with use of statistical analysis & design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation. This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome.  BS/MS in Mechanical, Electrical or Industrial Engineering & 15+ years’ experience managing an engineering group responsible for medical device development and manufacturing engineering with a strong history of hands-on experience is required. Also required Deep expertise in manufacturing automation for large scale manufacturing.

Director of Pilot Manufacturing – San Jose, CA

Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing.  This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.

Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.

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JOBS: April, 2019


Job search. Loupe with jobs classified ad newspapers isolated on white. 3d illustrationPlease see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail dot com.

Director of Pilot Manufacturing – San Jose, CA

Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing.  This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.

Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.

Director of Manufacturing Automation – San Jose, CA

This position requires a dynamic, energetic, self-driven, engineering leader with broad manufacturing engineering and automation experience & will report to VP of Manufacturing Operations. The Director of Manufacturing Automation will lead the development of fully automated manufacturing systems for all aspects of company’s disposable drug tablet manufacturing. This individual will be responsible for defining system requirements, developing proof of principle systems, developing timelines and managing budgets and providing direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. This individual will work closely with product development, manufacturing engineering and quality in order to ensure manufacturability, achievement of targets, and develop processes for optimum manufacturability.

Responsibilities: Define functional & detailed requirements & specifications for manu automation, including quality & regulatory requirements; Manage internal & external process automation programs, project schedules & budgets; Develop facility plans & specifications for manufacturing scale-up; Oversee installation & qualification of automated manu systems; Comply with USFDA cGMP regulations, (ISO), Company policies, operating procedures, processes & task assignments.

Requirements: Experience managing and leading complex cross functional projects involving, electrical, mechanical, quality aspects; Experience with mechatronics or automation engineering including machine, mechanism and fixture design; Strong problem solving and analytical skills; experience with use of statistical analysis & design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation. This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome.  BS/MS in Mechanical, Electrical or Industrial Engineering & 15+ years’ experience managing an engineering group responsible for medical device development and manufacturing engineering with a strong history of hands-on experience is required. Also required Deep expertise in manufacturing automation for large scale manufacturing

 

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FROSTNIXON – Play Review


Tony and Olivier Award nominated drama, Frost/Nixon is currently playing at www.theatreworks.org in Mountain View, CA. Written by Golden Globe winner Peter Morgan, the play focuses on 1977 television interviews between British journalist, David Frost (Jeremy Webb) and former President Richard Nixon (Allen McCullough).   

Even in 2019, the events surrounding the Presidency and resignation of Richard Nixon, stories of Watergate cover-up and Spiro Agnew’s criminal conduct, still holds the fascination and gets a great deal of attention in the media. At the time Nixon sat down for a series of interviews with David Frost, the Watergate scandal was still fresh in everyone’s minds and public was thirsty to hear from Nixon himself. There was a great deal of curiosity on whether contrition and guilt would find its way in his expression but Nixon continued to remain tight-lipped and when he did speak, he stayed short of admitting guilt.

Image result for frost/nixon, theatreworksTheatreworks production switches between on-camera Nixon, glib and defiant and off-camera Nixon, haunted by his own imagined ghosts, skeptical of everyone, socially inept and obsessed with money. The production also switches rapidly between on-camera Frost, also glib, confident, entertaining and at ease on camera and off-camera Frost, obsessing over the single most crucial and defining event of his life, his series of interviews with the defiant President of America, who had thus far managed to evade taking any responsibility.

Some of the most memorable and poignant moments of Nixon presidency were indeed marked by Television, like him defending himself in he “Checkers” speech, him protesting “I am not a crook”, and his resignation speech, to mention a few. But given his silence, it was hard to get Nixon to admit to the people, how he led and participated in one of the biggest scandals at the uppermost level in the American government. If it seemed reasonable to expect that when the moment come to nail down Nixon on his crimes, it must be a public moment where people may be watching him live on TV, sweating and all, David Frost did not seem to be a reasonable interviewer for such a high profile interview.  David Front won the interview for two simple reasons: He paid Nixon $600,000 from mostly his own money, and he was viewed by Nixon and his advisers as a pushover.

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Although David Frost was witty, insightful, entertaining and brought an informal touch to the interview, Nixon was a formidable adversary who was certain that he could hold his own. Having never testified or stood trial, Nixon was pardoned by Ford, and he never had to admit to or apologize for his deceitful conduct. So will Frost manage to nail Nixon on his favorite media, not Twitter but Television?!!  Frost’s team of producers and impassioned journalists, (Adam Shonkwiler, Patrick Russell, Stephen Muterspaugh) are all on edge, almost certain that Frost will mess it up and Nixon will just get a free pass. And Nixon’s team (Kenny Toll, Craig Marker, Adam J. Saucedo) were ready to bail the boss.

The showdown is imminent between these two men with their own private agenda. The stakes couldn’t be higher when these two ambitious men come face to face on camera, one who tried to undermine America’s democracy and the other trying to use the best weapon available in a democracy. What follows is a game of chess and a contest of wits. Even though many of us have lived through this history, this is a non-to-miss show of this theater season, certain to keep you riveted to the satisfying and portending, very end. Frost/Nixon is running at Mountain View Center for the Performing Arts and tickets can be purchased at www.theatreworks.org .

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Mothers and Sons – Play Review


Image result for citylights, mothers and sonsThe play “Mothers and Sons” by playwright, Terrence McNally and directed by Jeffrey Bracco is a funny and poignant tale of loss and love.  When Katharine (Lillian Bogovich), Andre’s mother shows up unexpectedly on the doorstep of Andre’s former boyfriend, Cal (Damian Vega), 20 some years after losing her son to AIDS, she is bitter, angry, hurt and in search of a target. Cal has also gone through deep loss but has found love again, in his husband Will (Max Tachis), and they have a son Bud (Izaiah Gutierrez), they deeply love. Still mourning and reeling from the loss of her son, Katharine sinks deeper into gloom at seeing Cal’s life. She asks, “why did your life got better after Andre and why did mine get worst”?

Image result for citylights, mothers and sonsAs per my observation however, this story is less about mothers and sons and more about one mother and her son. It is Katharine’s nature and temperament that has put her into an indefinite period of gloom and bitterness. She describes herself as “I am not a joiner, I did not like to cook, I am a widow”. Katherine could not cultivate intimacy and closeness with either her husband or her son, Andre.  She recalls Andre being “remote” and observes with some contempt that she was relegated to being a mere chauffeur. Many mothers might have experiences of similar moments but they put aside those moments and find more enduring closeness and love with their children.

While Katharine’s temperament may have precluded her from enjoying a close relationship with her son, this story is also wrapped in time when gays did not find acceptance in society and were subjected to biases and stereotypes. Katharine, found it hard to reconcile her preconceived notions about gays. She says, “I hate that word. It could be something nice, joyful. But we lost that battle too”. Sadly, her life is an endless series of battles she has brought onto herself.  And sadly, reeling in her own misery, she misses completely how an entire young generation of her son’s age was lost to AIDS epidemic, “a living, breathing generation, not a footnote in history”. Image result for citylights, mothers and sonsJust when it seems, there would be no hope for Katharine, then in the midst of sorrow, the characters find moments of compassion and glimmer of hope, and even love.  Mothers and Sons is a heartbreaking, emotionally nuanced story of unending mourning and loss and it is also a tale of human compassion where it is never too late to reconcile with one’s loss, only to stumble onto enduring nature of love. Lillian Bogovich as Katharine is absolutely amazing. This is a must-see play if only to watch the brilliant cast playing out the complex human drama with all the emotional nuances and with deep sensitivity. Mothers and Sons is running at the CityLights Theater in San Jose, till February 17, 2019 and tickets can be obtained at www.cltc.org .

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