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Assoc Director, Quality

Associate Director,
Quality Bioanalytical Development Method Validation

There is an Associate Director position available in Protein Analytical Chemistry, a part of Genentech's Quality Bioanalytical Development organization, to an accomplished individual with experience in method validation for commercial filings.  The responsibilities of this individual will include leading a group to oversee method validation for licensure of new products, developing efficient approaches to phase appropriate method qualification and validation, and ensuring compliance with GLP/GMP requirements and Genentech Quality Systems.

The successful candidate will have a Ph.D. (or equivalent) in chemistry, biochemistry, or a related area with 10+ years experience in a protein therapeutics Quality Control environment.  She/he must have demonstrated a solid understanding of GMP requirements for method validation and testing for US and European regulatory filings to support clinical development and licensure.  S/he must have the ability to develop, execute and defend phase-appropriate validation strategies.  Strong managerial skills are required, including hiring and developing staff.   The successful candidate is expected to exhibit strong teamwork and collaborative skills with outstanding verbal and written communication.


DIVISION:  Process Dev & New Manuf Facil
REQUISITION NUMBER:  09-1000028363