Senior Associate Outsourced Manufacturing
Overview
Lead the execution of manufacturing campaigns across Gilead’s global external contract manufacturing network to ensure uninterrupted supply of clinical and commercial products. Collaborate with Development Quality Regulatory Analytical Supply Chain and Product & Portfolio Strategy teams to drive technology transfer and manage routine supply. This role differs by focusing on cross‑functional partnership and strategic product lifecycle management.
What You'll Do11
- 1Execute network strategy for external manufacturing
- 2Manage supplier performance and contractual relationships
- 3Coordinate technical transfers between internal and external teams
- 4Partner with Technical Development and manufacturing sites for process validation
- 5Oversee regular management of CMOs to maintain compliance with cGMP and MPRs
- 6Resolve manufacturing issues and handle deviations complaints
- 7Drive continuous improvement initiatives to reduce cost and increase efficiency
- 8Foster sustainable production practices across the supply chain
- 9Represent manufacturing on cross‑functional Development or Commercial CMC teams
- 10Manage product strategy from clinical supply to commercial launch and routine supply
- 11Support product sunset or divestiture processes
Requirements9
- 1BA or BS degree in science or engineering with 5+ years of progressive pharmaceutical biotech experience
- 2MS or MBA may substitute for two years of relevant experience
- 3Proven experience in drug product manufacturing and supply chain oversight within pharma
- 4Working knowledge of worldwide regulatory requirements and ICH guidance
- 5Ability to travel internationally with up to 20% overnight trips required
- 6Exceptional verbal and written communication skills for senior management interaction
- 7Strong understanding of cGMP principles and manufacturing best practices
- 8Familiarity with CMO landscape and capabilities for worldwide drug product manufacturing
- 9Bachelor's degree in science or engineering with 5+ years of experience preferred
Salary Insight
$118 - $153k per year
Location
Required Skills
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