Senior Scientist, Raw Materials

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

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.

Qualifications:

• 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 b