Biologics QC Lead — Associate Director

Gilead Sciences Inc.; Foster City (CA); Sur place; USD 182 000 - 236 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Life insurance

Résumé du poste

Gilead Sciences Inc. in Foster City, CA, is seeking an Associate Director of Quality Control - Biologics QC Lead to provide strategic QC leadership for biologics programs across the product lifecycle.

You will partner with Analytical Development, QA, and Regulatory to develop phase-appropriate QC strategies enabling development, transfer, validation, regulatory submissions, and lifecycle management. The role requires deep QC knowledge of biologics, analytical methods, and cross-functional

Qualifications

• Ph.D. with 2+ years of industrial experience, or MS with 8+ years, or BS with 10+ years.
• Desirable advanced degrees (MS/MD/PharmD/PhD) are a plus.
• Experience in biopharmaceutical QC, analytical development, manufacturing sciences, or related quality function.

Responsabilités

• Serve as the QC Lead and primary QC point of contact for assigned biologics programs; represent QC on product teams and governance forums.
• Develop and maintain phase-appropriate, end-to-end QC strategies for biologic drug substance, drug product, intermediates, and relevant materials.
• Own or provide senior oversight of specifications and analytical methods.
• Provide QC oversight for testing at internal labs, CMOs/CDMOs, and contract testing labs; establish governance and testing-network strategies.
• Provide QC guidance for deviations, OOS/OOT, stability trends, and investigations.
• Lead QC governance initiatives and harmonization across modalities; mentor QC professionals and matrix teams.

Connaissances

Biologics QC

Analytical methods

Regulatory content

Quality systems

People leadership

Formation

PhD

MS

BS

Description du poste

Gilead Sciences Inc. in Foster City, CA, is seeking an Associate Director of Quality Control - Biologics QC Lead to provide strategic QC leadership for biologics programs across the product lifecycle.

You will partner with Analytical Development, QA, and Regulatory to develop phase-appropriate QC strategies enabling development, transfer, validation, regulatory submissions, and lifecycle management. The role requires deep QC knowledge of biologics, analytical methods, and cross-functional