Sr Manager, Outsourced Manufacturing

Gilead Sciences • Foster City, CA

6d • Onsite

About The Position

The Senior Manager, Global External Manufacturing (GEM) Oral-Solid Dosage (OSD) supports uninterrupted supply of Gilead clinical and commercial products through manufacturing campaigns across its global external contract manufacturing network. The role ensures compliance with cGMP, regulatory requirements, and environmental, health, and safety legislation. It is part of the Manufacturing Operations group within Pharmaceutical Development and Manufacturing (PDM), and oversees or contributes to technical and operational activities that sustain supply of externally manufactured products.

The position collaborates with Technical Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy teams to support technology transfer and validation, commercialization, launch, routine supply, and proactive lifecycle change management. It is based at Gilead’s Foster City campus and may require international travel, including overnight travel, up to 20% of the time.

Requirements

• At least 8 years of progressively responsible experience in a pharmaceutical or biotechnology organization, with a BA or BS degree in science or engineering.
• An MS or MBA may substitute for 2 years of relevant experience; a Ph.D. may substitute for 4 years of relevant experience.
• Experience and/or working understanding of manufacturing principles governed by current Good Manufacturing Practices (cGMP).
• Working knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance.
• Experience in drug-product manufacturing or technical operations and supply-chain execution and oversight in the pharmaceutical industry.
• Experience in manufacturing and quality risk management at external manufacturing sites.
• Ability to travel internationally, including overnight, up to 20% of the time.
• Strong computer, organizational, and project-management skills.
• Exceptional verbal, written, and interpersonal communication skills, including the ability to interact effectively with senior management at Gilead and contract manufacturing organizations.
• Demonstrated ability to understand and contribute to resolving complex situations.
• Experience in oral-solid dosage drug-product manufacturing and supply-chain execution and oversight in the pharmaceutical industry.
• Experience supporting regulatory inspections and audits in partnership with QA.
• Advanced expertise in vendor qualification, contract negotiation, and supplier performance management.

Nice To Haves

• An advanced degree in science, engineering, or business is desirable; an MS or MBA may substitute for 2 years of relevant experience, and a Ph.D. may substitute for 4 years.
• Knowledge of contract manufacturing organization capabilities and limitations for worldwide drug-product manufacturing.

Responsibilities

• Execute Gilead’s supply network strategy within Global External Manufacturing and contribute to defining technical requirements for selecting contract manufacturing organizations (CMOs).
• Lead or represent GEM on CMO Management Teams, influencing CMO performance and monitoring key performance indicators to achieve business outcomes and execution plans.
• Collaborate across PDM and with external partners to achieve departmental, cross-functional, and corporate goals.
• Execute inter-company and intra-company technical transfers; partner with Technical Development and internal Gilead manufacturing sites to transfer and validate processes and products at identified CMOs.
• Manage CMOs tactically to ensure products are manufactured according to the registered process and approved Master Production Record.
• Enable timely resolution of complex manufacturing, product-quality, and compliance issues, including finished-product trending, continued process verification, out-of-trend and out-of-specification investigations, change management, deviations, and product complaints.
• Provide on-site technical support at contract development and manufacturing organization (CDMO) sites as needed.
• Identify and facilitate continuous improvement initiatives to reduce costs, improve quality, increase efficiency, and ensure supply sustainability.
• Represent GEM on cross-functional PDM development or commercial teams as needed, managing product strategy across the lifecycle from clinical supply through launch and routine supply to sunset or divestiture.
• Write or review qualification, validation, technical, and deviation reports.
• Prepare documents for regulatory filings and review filings, including sections from other disciplines.
• Support regulatory inspections and audits in partnership with Quality Assurance.

Benefits

• Discretionary annual bonus may be available.
• Discretionary stock-based long-term incentives may be available; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.
• Benefits package, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior