LanceSoft Inc
Job Title: Contract Manufacturing Site Manager
Location: Foster City, CA - Hybrid
Contract Duration: 6 Months
Pay Range: $60.00 - $80.00 USD hourly on W2
Job Description: · Responsible within Global External Manufacturing to support the oversight of Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs. · Proactively and effectively work with other 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 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)
Any Disqualifiers? Must be flexible with work hours to support global network, either early morning (7 am) or evening (6pm) calls are frequent.
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Job Description: · Responsible within Global External Manufacturing to support the oversight of Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs. · Proactively and effectively work with other 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 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)
Any Disqualifiers? Must be flexible with work hours to support global network, either early morning (7 am) or evening (6pm) calls are frequent.
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