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 Expert  728425

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


Available for your Consulting and Expert Witness Needs

California (CA)
USA
Education Work History Career Accomplishments Consulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

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)
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acceptable quality level

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active pharmaceutical ingredient

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drug stability

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medical device

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medical device manufacturing quality control

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pharmaceutical drug

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pharmaceutical quality control

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quality control

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statistical quality control

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total quality control


Show Secondary and Basic Areas of Expertise
Localities:
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;  and Hayward, California.

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

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to 2009

 

Genentech

 

QC Stability

 

Sr. Product Specialist (Late stage and marketed)

 

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.

2003 to 2006

 

Depomed inc.

 

Quality Control

 

Senior QC Chemist/Analyst

 

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.

2000 to 2003

 

Connetics

 

Quality Control

 

Sr. QC Chemist

 

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

1999 to 2000

 

Chiron

 

Drug Discovery

 

Sr. Research Associate

 

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


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.


Government Experience:
Years   Agency   Role   Description
1995 to 1998   Department of Health Services   Brought lab up to DHS/ELAP standards for certification   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.
1995 to 1998   USACE (US Army Corp of Engineers)   Brought lab up to USACE standards for certification   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
1995 to 1996   AFCEE (Air Force)   Set up lab to AFCEE specifications to obtain certification   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
1995 to 1998   NEESA (Navy)   Set up lab to NEESA specifications to obtain certification   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

Consulting Services:
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
he has been identified as an expert witness for possible litigation
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

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

Language Skills:
Foreign Language   Description
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.

Market Research:
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.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
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

Supplier and Vendor Location and 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.

Other Skills and Services

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


 

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