Senior Scientist, Raw Materials

Gilead Sciences • Foster City, CA

1d

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Scientist, Raw Materials at Gilead you will be vital for the success of Clinical Biologics QC, providing strategic leadership and overseeing daily operations raw materials. Focus Areas: Manage the end to end lifecycle of GMP raw materials, including receipt, quarantine, sampling, testing coordination, release, storage, requalification, and expiry/disposal. ‑to‑end lifecycle of GMP raw materials, including receipt, quarantine, sampling, testing coordination, release, storage, requalification, and expiry/disposal. Ensure uninterrupted availability of raw materials to support manufacturing and laboratory testing through proactive inventory planning and risk management. Coordinate GMP sampling and testing activities for raw materials (e.g., chemicals, excipients, buffers, solvents, reagents), including internal QC and external laboratories. Review and maintain raw material specifications, Certificates of Analysis (CoAs), quality agreements, and supplier change notifications; support supplier and material qualification and requalification. Oversee storage, labeling, segregation, and status control of materials under appropriate environmental conditions; manage excursions and related investigations. Maintain accurate raw material records in electronic systems (e.g., LIMS, ERP, EDMS); perform inventory reconciliations, cycle counts, and data trending. Serve as a key point of contact for externally tested materials, coordinating internal stakeholders and external laboratories to ensure timely release. Review and manage deviations, OOS/OOT results, risk assessments, and CAPAs. Ensure inspection readiness and support internal and external audits. Collaborate cross‑functionally with Quality Control, Analytical Development, Regulatory Affairs, Quality Assurance, and Supply Chain to support method lifecycle, regulatory filings, and health authority inquiries. Author, review, and maintain GMP documentation, including protocols, reports, SOPs, deviations, change controls, CAPAs, and study closeout documentation. Collaborate cross‑functionally with QC, CMC, Regulatory Affairs, Manufacturing, and Supply Chain to support raw material commitments, filings, and health authority responses.

Requirements

• Experience with Biologics Quality Control with knowledge of industry best practices and trends for raw materials.
• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Must be able to develop and improve complex concepts, techniques, standards and new applications based on quality principles and theories.
• Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovation.
• Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.
• Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.
• Demonstrated the ability to influence process and outcomes across functions.
• 8+ Years experience with BS in Chemistry, Biochemistry or related field OR 6 + Years with MS in Chemistry, Biochemistry or related field OR 2+ Years with PhD in Chemistry, Biochemistry or related field
• Deep knowledge and experience in Biologics quality control.
• Stays ahead of shifting trends in industry.
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
• Strong organizational and planning skills.
• Shows excellent verbal and written communication skills and collaborative interpersonal skills.

Responsibilities

• Manage the end to end lifecycle of GMP raw materials, including receipt, quarantine, sampling, testing coordination, release, storage, requalification, and expiry/disposal.
• Ensure uninterrupted availability of raw materials to support manufacturing and laboratory testing through proactive inventory planning and risk management.
• Coordinate GMP sampling and testing activities for raw materials (e.g., chemicals, excipients, buffers, solvents, reagents), including internal QC and external laboratories.
• Review and maintain raw material specifications, Certificates of Analysis (CoAs), quality agreements, and supplier change notifications; support supplier and material qualification and requalification.
• Oversee storage, labeling, segregation, and status control of materials under appropriate environmental conditions; manage excursions and related investigations.
• Maintain accurate raw material records in electronic systems (e.g., LIMS, ERP, EDMS); perform inventory reconciliations, cycle counts, and data trending.
• Serve as a key point of contact for externally tested materials, coordinating internal stakeholders and external laboratories to ensure timely release.
• Review and manage deviations, OOS/OOT results, risk assessments, and CAPAs.
• Ensure inspection readiness and support internal and external audits.
• Collaborate cross‑functionally with Quality Control, Analytical Development, Regulatory Affairs, Quality Assurance, and Supply Chain to support method lifecycle, regulatory filings, and health authority inquiries.
• Author, review, and maintain GMP documentation, including protocols, reports, SOPs, deviations, change controls, CAPAs, and study closeout documentation.
• Collaborate cross‑functionally with QC, CMC, Regulatory Affairs, Manufacturing, and Supply Chain to support raw material commitments, filings, and health authority responses.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree