Associate Director, External Manufacturing & CMC

Biopharma Careers; Foster City (CA); On-site; USD 182,000 - 236,000; Full time

Benefits offered by this job

Health benefits

Bonus eligibility

Stock-based incentives

Job summary

Gilead Sciences Inc. in the United States is seeking an experienced leader to manage CMOs for Oral Solid Dose manufacturing, ensuring adherence to registered processes and master records.

You will coordinate tech transfers, drive continuous improvement, and partner with QA and senior management to align product strategies across lifecycle stages. The role requires strong GMP/ICH knowledge, external-site management experience, and excellent communication.

Qualifications

• Strong working knowledge of pharmaceutical GMPs and ICH regulatory guidance.
• Demonstrated experience managing external suppliers, contract manufacturers, warehouses, or logistics providers.
• Proven ability to interact effectively with senior management and cross-functional teams.
• Exceptional verbal and written communication skills.

Responsibilities

• Executes the regular, tactical management of CMOs to ensure Gilead’s Oral Solid Dose products are manufactured per registered process and Master Production Record.
• Enables timely resolution of manufacturing/compliance issues including deviations, complaints, OOS investigations, and change control.
• Coordinates inter- and intra-company tech transfers with Development and internal sites for successful transfer/validation of processes/products.
• Fosters continuous improvement to reduce cost, improve quality, and increase efficiency across production.
• Represents manufacturing on cross-functional CMC teams to manage product lifecycle from clinical supply to sunset.

Skills

GMPs knowledge

External suppliers mgmt

Senior mgmt communication

Regulatory guidance ICH

Cross-functional collaboration

Education

Bachelor's in Organic Chemistry/Chemical Eng

Master's in Organic Chemistry/Chemical Eng

Job description

Gilead Sciences Inc. in the United States is seeking an experienced leader to manage CMOs for Oral Solid Dose manufacturing, ensuring adherence to registered processes and master records.

You will coordinate tech transfers, drive continuous improvement, and partner with QA and senior management to align product strategies across lifecycle stages. The role requires strong GMP/ICH knowledge, external-site management experience, and excellent communication.