Pacer Group
Overview
Job Title: Contract Manufacturing Site Manager Location: Foster City Hybrid Duration: 12 months Role within Global External Manufacturing to support the oversight of Gilead Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs. Responsibilities
Proactively collaborate with QA, QC, Strategic Sourcing, Supply Chain, Regulatory, Portfolio Management to execute manufacturing strategy. Manage CMOs to ensure products are manufactured in accordance with the registered process and approved Master Production Record. Resolve complex manufacturing and compliance issues, including deviations, complaints, out-of-specification investigations, Material Review Board investigations, finished product trending, and change control. Foster and facilitate continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability. Qualifications
Required Years of Experience: 15+ 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 Additional Details
Unique Selling Point: Highly impactful role contributing to the advancement of innovative and transformative therapies. Seniority level: Associate Employment type: Contract Job function: Science Industries: Medical Equipment Manufacturing
#J-18808-Ljbffr
Job Title: Contract Manufacturing Site Manager Location: Foster City Hybrid Duration: 12 months Role within Global External Manufacturing to support the oversight of Gilead Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs. Responsibilities
Proactively collaborate with QA, QC, Strategic Sourcing, Supply Chain, Regulatory, Portfolio Management to execute manufacturing strategy. Manage CMOs to ensure products are manufactured in accordance with the registered process and approved Master Production Record. Resolve complex manufacturing and compliance issues, including deviations, complaints, out-of-specification investigations, Material Review Board investigations, finished product trending, and change control. Foster and facilitate continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability. Qualifications
Required Years of Experience: 15+ 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 Additional Details
Unique Selling Point: Highly impactful role contributing to the advancement of innovative and transformative therapies. Seniority level: Associate Employment type: Contract Job function: Science Industries: Medical Equipment Manufacturing
#J-18808-Ljbffr