Senior Scientist in Biologics Analytical Development (Pivotal and Commercial)

Gilead Sciences • Oceanside, CA

83d • $153,935 - $219,120

About The Position

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. Additionally, the ideal candidate should have experience working with pharmacopeial standards (e.g., USP, EP, JP), and have 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. 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.

Requirements

• 8+ Years with BS
• 6+ Years with MS
• 2+ Years with PhD/PharmD
• 0+ Years with MD

Nice To Haves

• 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, and other process related impurity method development and techniques commonly used for drug substance release testing and process characterization (e.g. ELISA).
• Subject matter expert in establishing comprehensive control strategies for biologics products.
• Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.
• Proven track record in drafting regulatory documentation at all stages, including IND, BLA, and PAS filings.
• Demonstrated ability of building strong collaborations with other CMC functions.
• Strong business acumen, with ability to balance resource, budget, and program milestones.
• Leadership qualities of the successful candidate include collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence.

Responsibilities

• Provide leadership to a group of scientists focused on impurities and compendial method development and testing and product understanding.
• Mentor and guide scientists in their roles.
• Set clear expectations and prioritize work packages.
• Recruit and hire new talent.
• Define process impurity and compendial testing and control strategy across the late-phase biologics portfolio.
• Drive 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.
• Deliver high quality work packages for supporting Pivotal INDa and marketing applications.
• Serve as an analytical development (AD) lead or analytical project lead (ASTL) for late-phase program.
• 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.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees