Fladger Associates
Responsibilities:
A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible. Excellent employment opportunity for a Contract Manufacturing Site Manager in the Foster City, CA area. Responsible within Global External Manufacturing to support the oversight of the Company Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs. Proactively and effectively work with other company functions (Quality Assurance, Quality Control, Strategic Sourcing, Supply Chain, Regulatory, Portfolio Management) to execute on manufacturing strategy. Executes the regular, tactical management of CMOs to ensure the Company’s products are manufactured in accordance with the registered process and approved Master Production Record Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability. Experience: Required Degree or Certification 4 year college (BS/BA in Science field) and 15+ years of experience Top 3 Required Skill Sets: GMP Manufacturing expertise in commercial Biologics Drug Substance, Communication (written and verbal), Decision making (prioritization, risk evaluation) Top 3 Nice to Have Skill Sets: Drug Product expertise, Technology Transfers, Clinical product manufacturing Any Disqualifiers? Must be flexible with work hours to support global network, either early morning (7 am) or evening (6pm) calls are frequent.
A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible. Excellent employment opportunity for a Contract Manufacturing Site Manager in the Foster City, CA area. Responsible within Global External Manufacturing to support the oversight of the Company Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs. Proactively and effectively work with other company functions (Quality Assurance, Quality Control, Strategic Sourcing, Supply Chain, Regulatory, Portfolio Management) to execute on manufacturing strategy. Executes the regular, tactical management of CMOs to ensure the Company’s products are manufactured in accordance with the registered process and approved Master Production Record Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability. Experience: Required Degree or Certification 4 year college (BS/BA in Science field) and 15+ years of experience Top 3 Required Skill Sets: GMP Manufacturing expertise in commercial Biologics Drug Substance, Communication (written and verbal), Decision making (prioritization, risk evaluation) Top 3 Nice to Have Skill Sets: Drug Product expertise, Technology Transfers, Clinical product manufacturing Any Disqualifiers? Must be flexible with work hours to support global network, either early morning (7 am) or evening (6pm) calls are frequent.