ACL Digital
Job Title: Manufacturing Site Manager
Location: Foster City, CA (Hybrid)
Duration: 6+ Months
If your skills, experience, and qualifications match those in this job overview, do not delay your application.
Job Description: · 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+ 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)
If your skills, experience, and qualifications match those in this job overview, do not delay your application.
Job Description: · 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+ 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)