Manager, Outsourced Manufacturing
Gilead Sciences
2 months ago
On-site
San Francisco Bay Area
Operations
Manager, Global External Manufacturing, Small Molecule Drug Substance (DS)
Essential Functions
- Execute the Global External Manufacturing network strategy; manage external manufacturing business execution and supplier performance.
- Collaborate with functions within and external to PDM to achieve corporate, cross-functional, and departmental goals.
- Coordinate inter- and intra-company technical transfers; partner with Technical Development and internal sites for technology transfer and validation of new or existing processes/products to identified CMO(s).
- Manage CMOs to ensure products are manufactured per the registered process and approved Master Production Record.
- Resolve manufacturing/compliance issues, including deviations, complaints, out-of-specification investigations, Material Review Board investigations, finished product trending, and change control.
- Drive continuous improvement to reduce cost, improve quality, increase efficiency, and ensure sustainability.
- May represent manufacturing on cross-functional Development or Commercial CMC teams and proactively manage product strategy across the lifecycle (clinical supply through launch and routine supply, then sunset/divestiture).
Basic Qualifications
- 6+ years of progressively responsible experience in a pharmaceutical/biotech organization.
- BA or BS degree in science or engineering.
- MS or MBA may substitute for 2 years of relevant experience; PhD may substitute for 4 years of relevant experience.
Preferred Qualifications
- Experience in drug substance manufacturing and supply chain execution/oversight.
- Working understanding of cGMP and worldwide regulatory requirements (including ICH guidance).
- Knowledge of the contract manufacturing organization (CMO) landscape (CMO capabilities/limitations for worldwide drug product manufacturing is a plus).
- Ability to travel internationally (overnight up to 10%).
- Exceptional verbal and written communication skills; ability to interact effectively with senior management and CMO organizations.
Benefits (as stated)
- Company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.
Essential Functions
- Execute the Global External Manufacturing network strategy; manage external manufacturing business execution and supplier performance.
- Collaborate with functions within and external to PDM to achieve corporate, cross-functional, and departmental goals.
- Coordinate inter- and intra-company technical transfers; partner with Technical Development and internal sites for technology transfer and validation of new or existing processes/products to identified CMO(s).
- Manage CMOs to ensure products are manufactured per the registered process and approved Master Production Record.
- Resolve manufacturing/compliance issues, including deviations, complaints, out-of-specification investigations, Material Review Board investigations, finished product trending, and change control.
- Drive continuous improvement to reduce cost, improve quality, increase efficiency, and ensure sustainability.
- May represent manufacturing on cross-functional Development or Commercial CMC teams and proactively manage product strategy across the lifecycle (clinical supply through launch and routine supply, then sunset/divestiture).
Basic Qualifications
- 6+ years of progressively responsible experience in a pharmaceutical/biotech organization.
- BA or BS degree in science or engineering.
- MS or MBA may substitute for 2 years of relevant experience; PhD may substitute for 4 years of relevant experience.
Preferred Qualifications
- Experience in drug substance manufacturing and supply chain execution/oversight.
- Working understanding of cGMP and worldwide regulatory requirements (including ICH guidance).
- Knowledge of the contract manufacturing organization (CMO) landscape (CMO capabilities/limitations for worldwide drug product manufacturing is a plus).
- Ability to travel internationally (overnight up to 10%).
- Exceptional verbal and written communication skills; ability to interact effectively with senior management and CMO organizations.
Benefits (as stated)
- Company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.