Expert Details
Designing and Implementing Quality Control Stability Programs, Authoring Stability Sections
ID: 728425
California, USA
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 |
|---|---|---|---|
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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 |
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| Years | Employer | Title | Department |
| 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 |
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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. |