Expert Details

Expert in Designing and Implementing Quality Control Stability Programs, Authoring Stability Sections

Expert ID: 728425 California, USA

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Expert has over 10 years experience in the areas of QC Stability (Drug Product and API). In addition, Expert has many years of experience in drafting QC Stability sections for the following submissions for the FDA: IND, NDA, BLA, PAS, CBE-30. Expert also has experience in authoring Type II variations for the EMEA. In addition, Expert has experience with the stability of Combination Products and Medical Devices. With this experience, Expert has been able to rapidly obtain approval by both the FDA and the EMEA for Drug Product (Antibodies and Small Molecules)

Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California

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Education

Year Degree Subject Institution
Year: 1991 Degree: BS Subject: Molecular Biology Institution: University of California at Santa Cruz

Work History

Years Employer Title Department Responsibilities
Years: 2006 to 2009 Employer: Genentech Title: Sr. Product Specialist (Late stage and marketed) Department: QC Stability Responsibilities: Design and implement QC Stability studies for new and existing Drug product and API. Perform trending on stability data. Author stability sections of INDs, NDAs, BLAs, PAS, CBE-30, ARs, APRs and Type II Variations (EMEA). Participate in audits. Conduct investigations for OOT/OOS events as well as CAPAs.
Years: 2003 to 2006 Employer: Depomed inc. Title: Senior QC Chemist/Analyst Department: Quality Control Responsibilities: Conduct analysis of release and stability drug product. Develop and validate analytical methods. Design and set up raw materials testing lab. Perform cleaning validation on pilot plant.
Years: 2000 to 2003 Employer: Connetics Title: Sr. QC Chemist Department: Quality Control Responsibilities: Expert would perform analysis on release and stability drug product samples. Develop and validate analytical methods. Work to support the formulations department by analyzing small scale API and Drug Product
Years: 1999 to 2000 Employer: Chiron Title: Sr. Research Associate Department: Drug Discovery Responsibilities: Expert would perform screening and characterization of new small molecule candidates. Primarily Expert determined the pKa, Log P and Log D of the new molecules of interest. In addition, Expert designed analytical test methods using LC/MS and MALDI TOF MS

Government Experience

Years Agency Role Description
Years: 1995 to 1998 Agency: Department of Health Services Role: Brought lab up to DHS/ELAP standards for certification Description: Expert set up all testing labs and made them compliant with government regulations. In addition, Expert reviewed and approved all data generated at the site.
Years: 1995 to 1998 Agency: USACE (US Army Corp of Engineers) Role: Brought lab up to USACE standards for certification Description: Expert set up all testing labs and made them compliant with government regulations. In addition, Expert reviewed and approved all data generated at the site. He was also the point person in Audits
Years: 1995 to 1996 Agency: AFCEE (Air Force) Role: Set up lab to AFCEE specifications to obtain certification Description: Expert set up all testing labs and made them compliant with government Expert set up all testing labs and made them compliant with government regulations. In addition, Expert reviewed and approved all data generated at the site. He was also the point person in Audits
Years: 1995 to 1998 Agency: NEESA (Navy) Role: Set up lab to NEESA specifications to obtain certification Description: Expert set up all testing labs and made them compliant with government Expert set up all testing labs and made them compliant with government regulations. In addition, Expert reviewed and approved all data generated at the site. He was also the point person in Audits

International Experience

Years Country / Region Summary
Years: 1995 to 1996 Country / Region: Mexico Summary: As the lab director for Onsite Environmental Labs, Expert was responsible for setting up and auditing the Mexican office

Career Accomplishments

Associations / Societies
Expert Belongs to RAPS
Licenses / Certifications
DHS/ELAP certification,
USACE certification,
AFCEE certification,
NEESA certification

Professional Appointments
Attendant at DRB review board meetings,
Attendant at CMC-ARC and CMC-RAC meetings,
Attendant at all CMC and subteam meetings as a rep for QC Stability.
Expert was appointed to the position of E4 from E3 in 2008. E4 is a managerial level position.
Awards / Recognition
Multiple awards from Genentech for outstanding work.

Additional Experience

Expert Witness Experience
he has been identified as an expert witness for possible litigation
Training / Seminars
Attended: Seminar in QC Stability.
Attended: Seminar in developing methods using KF volumetric titration.
Attended: Seminar on Agilent GC and GC/MS.
Attended: Seminar on using Brookefield viscometers
Vendor Selection
H has had experience in subbing out stability studies to CMOs. He designed the quality agreement and stability studies for several CMOs.

He has usually performed a search on the web for vendors and suppliers. He would make an appointment to see them, see their services and then pick the vendor supplier with the superior product balanced with cost.
Marketing Experience
At Genentech he decreased the testing schedule for certain drug products. he did this by removing old, imprecise methods for drug testing (ie replace IEF with IEC or replace SDS-PAGE with SEC HPLC). he also reduced the testing schedule timepoints for a number of drug substances and drug products. For all of the above cases, he consulted with the FDA and EMEA.
Other Relevant Experience
Rather extensive experience with Analytical instrumentation,
Ability to conduct cleaning validations on the pilot plant,
Excellent trouble shooting ability for instrumentation and methods,
Trending (using Arhenius plots),
Ability to design and validate analytical methods,
Technology transfer,
Proficiency with various statistical techniques (Ananova, Anacova),
Experience with audits (FDA, EMEA, Japanese Pharmacopeia),
Expertise with a wide variety of software for both sample and statistical analysis. He is familiar with the following software applications:

MicrosoftWord, Excel, Jmp, Kaleidograph, Chemstation, Millenium, Excalibur, LIMS, Systems, Trackwise, Novaweb, Novamanage, Empower, PeakPro, POMS Lot Trace, SAP

Language Skills

Language Proficiency
French Expert studied French for 4 years and spent time in France during an exchange program. Expert also spent time in other francophone regions like French Polynesia.
Spanish He studied Spanish for one year.

Fields of Expertise

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