Gilead Sciences
Senior Scientist in Biologics Analytical Development (Pivotal and Commercial)
Gilead Sciences, Oceanside, California, United States, 92058
Overview
Senior Scientist in Biologics Analytical Development (Pivotal and Commercial) 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 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. Note: 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. 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. 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. Deliver high quality work packages for supporting pivotal INDs and marketing applications. Serve as an analytical development lead or analytical project lead for late-phase program. Serve as an author and reviewer of CMC sections in regulatory filings; support interactions with health agencies. Collaborate with 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. Basic Qualifications
8+ years with BS; 6+ years with MS; 2+ years with PhD/PharmD; 0+ years with MD Preferred Qualifications
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 (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 (IND, BLA, PAS). Demonstrated ability to build strong collaborations with other CMC functions. Strong business acumen, with ability to balance resources, budget, and program milestones. Leadership qualities including collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources. People Leader Accountabilities
Create inclusion - value diverse teams and embed inclusion in management practices. Develop talent - coach employees on performance and potential, providing feedback for growth. Empower teams - align goals and organizational objectives, remove barriers, and connect to the broader ecosystem. Compensation and Benefits
The Salary Range For This Position Is: Other US Locations: $153,935.00 - $199,210.00; Bay Area: $169,320.00 - $219,120.00. Compensation depends on experience and location. This position may be eligible for discretionary bonus, stock-based incentives, and a benefits package. Benefits include medical, dental, vision, and life insurance plans. For additional benefits information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing. Equal Opportunity
Gilead Sciences Inc. is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or protected characteristics, in accordance with applicable laws. For accommodations, contact ApplicantAccommodations@gilead.com. For more information, see the Know Your Rights poster and related policies. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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Senior Scientist in Biologics Analytical Development (Pivotal and Commercial) 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 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. Note: 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. 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. 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. Deliver high quality work packages for supporting pivotal INDs and marketing applications. Serve as an analytical development lead or analytical project lead for late-phase program. Serve as an author and reviewer of CMC sections in regulatory filings; support interactions with health agencies. Collaborate with 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. Basic Qualifications
8+ years with BS; 6+ years with MS; 2+ years with PhD/PharmD; 0+ years with MD Preferred Qualifications
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 (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 (IND, BLA, PAS). Demonstrated ability to build strong collaborations with other CMC functions. Strong business acumen, with ability to balance resources, budget, and program milestones. Leadership qualities including collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources. People Leader Accountabilities
Create inclusion - value diverse teams and embed inclusion in management practices. Develop talent - coach employees on performance and potential, providing feedback for growth. Empower teams - align goals and organizational objectives, remove barriers, and connect to the broader ecosystem. Compensation and Benefits
The Salary Range For This Position Is: Other US Locations: $153,935.00 - $199,210.00; Bay Area: $169,320.00 - $219,120.00. Compensation depends on experience and location. This position may be eligible for discretionary bonus, stock-based incentives, and a benefits package. Benefits include medical, dental, vision, and life insurance plans. For additional benefits information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing. Equal Opportunity
Gilead Sciences Inc. is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or protected characteristics, in accordance with applicable laws. For accommodations, contact ApplicantAccommodations@gilead.com. For more information, see the Know Your Rights poster and related policies. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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