Description

Job Title: Contract Manufacturing Site Manager

Location: Foster City Hybrid

• Responsible within Global External Manufacturing to support the oversight of Client Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs.
• Proactively and effectively work with other Client 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 Client’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.

Required Years of Experience: 15+ years

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

Unique Selling Point of this role:

• “Highly impactful role contributing to the advancement of innovative and transformative therapies.

Required Degree or Certification

• 4 year college (BS/BA in Science field)

Any Disqualifiers?

• Must be flexible with work hours to support global network, either early morning (7 am) or evening (6pm) calls are frequent.