Senior Scientist in Biologics Analytical Development; Pivotal and Commercial

Senior Scientist in Biologics Analytical Development (Pivotal and Commercial)

Job Description

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 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

The Analytical Operations department is seeking a highly motivated Senior Scientist to lead our impurities development team. The ideal candidate must possess strong leadership skills to drive the development and testing of ELISA (host cell protein, protein

A), DNA, and other kinetic or end-point plate-based assays. A strong understanding of regulatory expectations, risk assessment, and impurity profiling in biopharmaceutical development is essential. The candidate should be adept at troubleshooting complex assays, interpreting data, and driving innovation in HCP monitoring to support process development and product characterization. The ideal candidate should have experience working with pharmacopeial standards (e.g., USP, EP, JP) and familiarity with regulatory expectations and quality control environments.

The candidate should be capable of interpreting compendial updates, ensuring compliance, and supporting cross-functional teams in method lifecycle management and troubleshooting.

Relocation

At a future date, this position will relocate from Oceanside CA to the Gilead corporate HQ in Foster City CA or will be hired directly to Foster City CA.

• Provide leadership to a group of scientists focused on impurities and compendial method development and testing and product understanding, including:
• Mentor and guide scientists in their roles.
• Set clear expectations and prioritize work packages.
• Recruit and hire new talent.

• Accountable for:
• Defining process impurity and compendial testing and control strategy across the late-phase biologics portfolio.
• Driving continuous improvement of process impurity strategies.
• Support the design/justification/execution of end-to-end control strategy development through a proactive definition of the product quality targets.
• Delivering high quality work packages for supporting pivotal INDs and regulatory marketing applications.

• Serve as an analytical development (AD) lead or analytical project lead (ASTL) for late-phase programs.
• Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies.
• Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful commercialization of the late-stage Biologics portfolio.
• Act as a key member of the extended Analytical Development leadership team to shape late-stage development strategies.
• Recruit, hire, and mentor talent to help cultivate a world class Biologics AD organization.

• 8+ years with BS or equivalent
• 6+ years with MS
• 2+ years with PhD/PharmD
• 0+ years with MD

• PhD in Chemistry or a related discipline with at least 3 years industry experience, or BS or MS degree with extensive industry experience.
• Significant expertise in HCP, host cell DNA,…