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Job #03369

About our client Our client is a young venture-backed organization headquartered in California that is focused on the development and commercialization of innovative biotechnology-based therapeutics. The company recently received a significant infusion of funding from premier investors and boasts an experienced management team at the helm to drive their programs forward. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Director of Quality Control California Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure agreed upon objectives are achieved on time 2) Generate chemistry, manufacturing and control data as well as documentation 3) Assist in product development and leading QC activities 4) Identify QC programs for lead products 5) Lead development and qualification/validation of test methods 6) Manage characterization efforts for API and impurities 7) Develop, review and approve stability studies 8) Assist in setting and approving specifications 9) Participate in formulating CMC information 10) Approve specifications, stability studies and method development/qualification documents 11) Drive characterization programs for CMC documentation Requirements 1) Advanced Science degree preferred 2) 8 – 10 years of industry experience in quality control 3) Experience in global (i.e. US, EU and Asia-Pacific) CMC requirements and documentation for end-of-phase 2 meeting, phase 3 study start and NDA 4) Experience in method development/validation requirements for common analytical methodologies 5) Experience in evaluating, setting and justifying product specifications 6) Experience in the medical device industry a plus 7) Working knowledge of common drug substance and drug product analytical methods as well as development/execution of their stability studies 8) Knowledge of cGMPs (as appropriate for QC) 9) Ability to drive execution through others including outsides contractors, consultants or staff not under direct control 10) Ability to perform even with limited resources 11) Personal flexibility with a desire to lead, learn and achieve in a collaborative environment