JOBS – January, 2022

Senior R&D Mechanical Engineer – N. San Jose, CA

This is a very exciting opportunity to work at grounds level on a stealth mode project, with a veteran entrepreneur, with several successful prior ventures. Requires 8+ years of medical device product development experience and strong expertise in Solidworks.

Senior Manufacturing Engineer – S. San Jose, CA

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

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

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

Director of Clinical Operations – N. San Jose, CA
Unique vascular startup with state of the art catheter development, with platform technology has an immediate opportunity to staff clinical and regulatory positions at all levels. Stay tuned for full JD – coming soon.

Bioanalytical Scientist – N. San Jose, CA

There is an exciting immediate job opportunity for a bioanalytical scientist in San Jose, CA to work on novel drug device combinations for treating chronic diseases. There are three opportunities and position, salary and benefits will be commensurate with experience. This position will be involved in the development of in vitro/in vivo models by performing a variety of microplate assays; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality; Perform routine data management tasks; Support regulatory efforts; Perform other duties as assigned.

Requirements: BS with 2-5 years or MS with 0-3 years or Ph. D. with 2+ years of industry experience is required; Also required, Experience in preclinical & clinical research; experience in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS; Experience with microplate assays; Hands-on experience in automation and liquid handling in a bioanalytical lab setting; Experience working with statistical software like Excel, GraphPad Prism and Softmax Pro; and Experience with writing reports/protocols and SOPs. Experience with Luminex MapX technology is an advantage.

R&D Scientist – N. San Jose

A drug delivery company with unique technology to deliver biologics has an exciting job opportunity in San Jose, CA for R&D Scientist.  

Requirements: BS/MS in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or related; 5+ years pharma or biotech experience in biologics analytical development, particularly, experience in biophysical techniques and analytical characterization of peptides and proteins is a must. Candidates must have experience of working in GLP/GMP regulated environment and working knowledge in product formulation (solid oral dosage, and/or parenteral sustained release) and process development from early to late phase development or at minimum hands on experience in providing analytical support to these activities. Also required, knowledge of state of the art analytical techniques such as various HPLC modes and detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell based assays etc for product characterization, comparability testing and PK/PD analyses. Experience in working with drug-device combination products is a plus.
Responsibilities:  Assessing chemical and physical stability of formulations and identifying appropriate stability, manufacturability, and performance critical quality attributes; Establishing and managing reference standard and stability programs; Participate in method and tech transfer from R&D to Manufacturing as appropriate; Writing, reviewing and approving CMC sections of regulatory filings; Assessing utilization of resources and identifying when, and where additional resources may be needed; Communicate effectively to the project team and present data at team meetings; Maintain high quality documentation of all activities in notebooks, Other duties as explained.

Molecular Biologist – South San Francisco, CA

An early stage biotechnology company located in S. San Francisco, CA has developed patented technology for engineering mammalian cells to vastly increase their productivity for therapeutic protein or virus production and has an exciting opportunity for senior molecular biologist. 

Requirements: Must have PhD in a related field or equivalent amount of experience with recombinant mammalian cell line creation; mammalian cell culture expertise; experience with general molecular biology techniques for designing and constructing vectors and transfecting mammalian cells; experience with protein assay techniques for screening transfected cells. Also highly preferred, Experience with flow cytometry, virology, cell banking, transposase transfection methods; experience with protein analytical methods; knowledge of the regulatory environment related to creating and testing cells destined for GMP manufacturing; and photomicroscopy.

Responsibilities: This position is responsible for helping develop the technology toward full commercialization. Responsibilities include work with cell engineering, vector design and construction, transfection, mammalian cell culture, cloning and screening, flow cytometry, and other related molecular and cellular biology techniques. 

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

Dems please stay engaged!!

This message is for my democrat friends who are losing hope. Increasingly and with rising sense of concern and alarm, we notice the disappointing and cowardly behavior from Republican leaders and citizenry. I notice many Democrats are losing hope. At such a time of divisiveness, I want to point your attention to something else that is simultaneously happening and perhaps indicates things to come, in the near future. 

First let me quote two anecdotal items. Recently I met a friend who is a dedicated trumper. He is a person who believes that the US should get broken into two countries so Republicans can have what they want in “their” country. He has taken the vaccine and the booster but does not believe in vaccines or the masks. We had this conversation.

He: All people who have taken vaccines are still getting covid. I am not going to take any more boosters if they come.
Me: But vaccines and boosters are keeping people safer and many of them out of hospitals.
He: How many exactly have stayed out of hospitals due to the booster?
Me: I don’t have specific numbers here.
He: So you just have a perception?
Me; No. There are some facts that can be checked and verified. So don’t ask me to do all the work. Instead, why don’t you try to check the facts by googling them? And instead of only tuning into Fox, also try tuning into CNN, MSNBC etc. to know about covid.
He: I am not going to. I don’t even listen to Fox. I don’t listen to any news. Sometimes I read some blogs. 

Another example. I saw on MSNBC, one journalist interviewing some Trumpers. One woman has 3000 connections on FB (she hasn’t met over 90% of them). She sends out many forwards on how the election was stolen from Trump and there were few others with the same beliefs. Many of them don’t even listen to right wing media like FOX and they do not trust fact checkers of companies like FaceBook (who are not politicians). In fact, some fact checkers employed by FB have even gotten death threats. 

SO here is the point. 

We are on a cusp of massive transformation and overhaul. Everything that is happening right now is precursor to massive transformation. Right now muck is rising to the top. As they say, it is darkest before the dawn. Isn’t it often the case in history that the muck that rises to the top, eventually gives an impetus for change in society? That is where we are. On one hand, all attempts to negate science and facts, is massively disappointing. AND YET, on the other hand, THAT is the beauty of living in this time that all the muck, false beliefs and insanity are coming out in the open. 

For instance, think of Jeffrey Epstein. He molested so many young girls for so long. When it all surfaced, it was extremely anger provoking. And yet, at least it surfaced and the guilty ones can then be held accountable. 

Also, let’s think of what is happening on the other side. My trumper friend is not listening to FOX along with CNN and MSNBC. He occasionally reads blogs. They are getting disillusioned and disengaged. Slowly many of them will go back to living on the periphery until and when they integrate true information or their children do. 

Why did I write this? I See a lot of disappointment among Dems. Biden can’t make progress, Dems are divided, some in the President’s own party won’t let him pass his bills that they originally believed in, Republicans continue to subscribe to falsehoods etc. SCOTUS continues to remain right leaning and the left continues to fear that with gerrymandering and lack of voting rights reform, the majority may lose due to technicalities. I fear this as well.

And yet Republican leaders are not all united. They are fully aware that the only strategy they have is to block and obstruct but that is not a strategy to govern. Mr. Trump has obfuscated their focus and it will not be easy for them to unite behind a nominee or a message. And consider the people who subscribe to conspiracies. They are divided as well. In fact, many are also divided within their own minds. Many of their beliefs in such conspiracies as the election was stolen, have become riddled with doubt. Some cling half-heartedly to what they knew to be true and some prefer to check out with occasional rants about how they would prefer secession. These assertions may sound more extreme but there is only fluff underneath the conspiracies and extreme stands they choose to take. 

So my friends, it is fine with taking occasional breaks from the news as we all must take care of our health and manage stress. And yet, stay engaged. If it is any help – remember, that a massive transformation needs for things to break down and not work for most. And this year we will likely see the transformation happen. When that happens, we want all hands on deck — all systems engaged – all people fully awake and contributing in building a better tomorrow.

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

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

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

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

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

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

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

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

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

 

JOBS – November, 2015

Please see below some of my immediate opportunities. All opportunities are for candidates located in the United States only.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

Research Associate/ Scientist – San Jose, CA
Innovative, well funded startup with novel drug-delivery technology has an immediate opening for research associate, in San Jose, CA.  Requirements include, solid track record in bioanalytical assays.  Proficiency in HPLC, Elisa immunoassays, luminescence assays, fluorescence assays or related is required.  Experience in quantitative analysis, variability analysis in tissue and plasma, experience in pharmacokinetics, and experience in biologics a big plus.  Stocks and benefits make this a highly attractive opportunity to be involved in cutting edge technology, at grounds level.  

CLS Lab Manager – Santa Clara, CA

Minimum Qualifications:
The lab manager must possess an active, valid license issued by the State to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties they are supervising; and– appropriate to the specialty or specialties for which they are consulting and, for the specialties of diagnostic immunology, chemistry, hematology, and microbiology, must–
(1) Have earned a bachelor’s degree in a chemical, physical or biological science or medical technology from an accredited institution; (CLS required)
(2) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty or subspecialty in which they supervise.

Duties and Responsibilities:
The lab manger shall be accessible to testing personnel at all times testing is performed by providing on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director.
The lab manager shall be responsible for ensuring that tests and examinations are performed in compliance with chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 standards as published October 1, 1994, regarding clinical laboratories and–
(1) Be responsible for providing day-to-day supervision of high complexity test performance by a testing personnel;
(2) Be responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
(3) Assure that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications;
(4) Ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning;
(5) Provide orientation to all testing personnel;
(6) Ensure proper training and competency assessment of all supervised laboratory personnel;
(7) Ensure that Proficiency Testing procedures are followed as specified in Proficiency Testing Procedure;
(8) Timely review of all data and programs specified in the Quality Assessment Procedure as authorized

Project Manager with strong hands-on engineering plus bio background – Milpitas, CA

This is an exciting opportunity with a huge potential upside in stocks in a very innovative company with unique drug delivery technology.  Strong technical background plus background in pharma chemistry and 10+ years experience with microsoft projects is ideal.  Drug-delivery device experience, a big plus.   

Director of Quality Engineering – Milpitas, CA

There is an immediate opportunity for Director of Quality Engineering.  It requires 10+ years experience in implantable device.  Some pharma experience highly desired.  Experience in implementing QE systems, a great plus.  This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential.  Requires engineering background.

Director of Manufacturing Engineering – Milpitas, CA

There is immediate opening for Director of Manufacturing, that requires 10+ years experience in implantable devices.  Experience with injectible drugs, pills highly desired.  Strong hands-on expertise in tooling is required.  This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential (a once in a lifetime kind of an opportunity).  

Post-doc opportunity – San Jose, CA

There are opportunities for some excellent post-docs for a drug delivery company.  These opportunities are for candidates with recent Ph.D. in Biochemistry or related and interest in obtaining exciting industrial post doc opportunity with exciting startup.

Senior Biochem Scientist- San Jose, CA

More details will be posted soon.  Meanwhile, candidates with strong drug delivery experience, please contact me.

Senior Quality Engineer – San Antonio, TX

Key Responsibilities
* Lead Quality Assurance for R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support facilities in CA & TX.
* Educate colleagues and support in-house uptake and implementation of these systems organization-wide
* Support the following functions: o Regulatory Affairs o Intellectual Property
* Business and Commercialization, including due diligence documentation
* Implement documentation systems, including electronic systems, under the functional direction of QA Director
based in San Jose

Key Qualifications
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial drug-device
and Class III experience desirable. At least 10 years experience, >15 years desirable.
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Grown QA organizations with a hands-on, leadership- by-example and team-oriented approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE • Supported multiple complex projects and start-ups
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class II and III implantable devices
* Strong technical skills with demonstrated ability to provide hands-on solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator

Key Job Parameters
* Full-time position located in San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Clinical Data Manager – Dublin, CA

Clinical Supplies Contractor – Dublin, CA

Lean Drug Development Model based on Operational Efficiency & Shared Risk

Lean Drug Development Model based on Operational Efficiency & Shared Risk

Madhav Reddy, founder of Maya Clinicals, a Northern California based CRO, talked about a novel risk sharing, open model of drug development at http://www.bio2devicegroup.org . This new, lean drug development model sidesteps the traditional development paths and avoids committing large blocks of capital before human efficacy is proven.

No one can deny that the drug development process needs an overhaul. It takes 9 therapeutics in phase 1 to get 1 to market and number of novel drugs coming out has been flat, though expenses keep climbing up. Perhaps the big pharma overspends or relied too heavily in the past, on block busters or FDA needs to change the risk tolerance profile; but something needs to be done, whilst keeping in mind that drug development ultimately depends on basic science, said Reddy. Different models for more efficient drug development, are explored that include, university collaborations, orphan indications, strategic relationships, biomarkers, soft ware modeling, genomics, high throughput screening and so on.

What we need is breakthrough in basic science or a new operating model and an ability to get toxicity and efficacy data to push R&D productivity, at lower cost. There is no shortage of IP and big Pharma also excels at commercializing. But the so called valley of death that sucks up resources, is right in between the IP and commercialization, said Reddy. Before spending large blocks of cash, people want to see proof of efficiency and safety. Smaller companies often do not have adequate resources to execute these studies fully. Also, their resources get divided among their core focus and other tangential concerns like fundraising, team assembly and so on. While the big pharma has the resources, a problem is that a project with gravity sucks in the resources and many early stage compounds are dropped before they are fully investigated, in the early stage.

Reddy said, his new model for quick turn drug development addresses both the lack of parallelism at big pharmaceutical companies and the resource limitations of start-up companies. Maya Clinicals is a CRO, deeply focused on clinical trials and related logistics and is based on an operational platform with all the crucial pieces required for success. They are asking biotech companies to focus on their core strength, their compound and Maya would push it through, with efficient use of infrastructure, shorter startup and execution, efficiency in distributed setup, and geographic savings. Besides doing this in a fee for service model, Maya is also willing to share the risk and participate in the upside. Utilizing Maya’s operational efficiency, and equity sharing model a development program can be brought down to 1/10 of the traditional cost. Compared to the traditional model however, the owners of the compound will have to give up a large portion of the equity in return for the increased speed and lower development cost.

With this new model, Maya Clinicals is counting on boosting its pipeline, run parallel programs in identical indications, and overcoming the limitations of startup model, and get the upside from equity sharing based on its operational efficiency. Maya is not counting on its ability to pick compounds at this stage. Instead, Maya is picking proven entrepreneurs and then relying on mathematical probabilities of success. Maya does not have a preference but indicated that that re-purposed compounds, and those targeting infectious diseases will be quickest. Maya is clear however, that its core ability is not in choosing a compound but in pushing it through and getting a faster idea of its probability of success, based on basic science. The talk was followed by Q&A.