Gilead Sciences
Senior Scientist in Biologics Analytical Development (Pivotal and Commercial)
Gilead Sciences, San Francisco, California, United States, 94199
Overview
Senior Scientist in Biologics Analytical Development (Pivotal and Commercial) at Gilead Sciences. The role focuses on leading impurities development, testing, and regulatory supporting activities within the Analytical Operations department. Responsibilities
Provide leadership to a group of scientists focused on impurities and compendial method development and testing and product understanding. Mentor and guide scientists; 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 impurity strategies. Support design/justification/execution of end-to-end control strategy development and product quality targets. Deliver high-quality work packages for supporting Pivotal INDs and marketing applications. Serve as analytical development lead or analytical project lead for late-phase programs. Author and review CMC sections in regulatory filings; support interactions with health agencies. Collaborate 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. Be a key member of the extended Analytical Development leadership team to shape late-stage development strategies. Recruit, hire, and mentor talent to cultivate a world-class Biologics AD organization. Basic Qualifications
8+ years with BS degree 6+ years with MS degree 2+ years with PhD/PharmD 0+ years with MD Preferred Qualifications
PhD in Chemistry or related discipline with at least 3 years industry experience, or BS/MS with extensive industry experience. Significant expertise in HCP, host cell DNA, and other process impurity method development (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. Proven track record in drafting regulatory documentation (IND, BLA, PAS). Demonstrated ability to build strong collaborations with CMC functions. Strong business acumen; ability to balance resources, budget, and milestones. Leadership: collaboration, building high-performing teams, accountability, cross-functional engagement, program management, strategic vision, executive presence. People Leader Accountabilities
Create inclusion; model inclusion and embed diversity in management. Develop talent; coach employees on performance and potential, provide feedback for growth. Empower teams; align goals and remove barriers to connect teams to the broader ecosystem. Salary and Benefits
Salary ranges vary by location: Other US Locations $153,935.00 - $199,210.00; Bay Area $169,320.00 - $219,120.00. Compensation includes base salary, discretionary bonus, stock-based incentives, PTO, and benefits (medical, dental, vision, life insurance). Benefits information available at Gilead Careers site. Additional Information
Gilead is an equal opportunity employer; information about rights and accommodations is provided in the company policy. Employees may apply via the Internal Career Opportunities portal in Workday for current employees and contractors.
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Senior Scientist in Biologics Analytical Development (Pivotal and Commercial) at Gilead Sciences. The role focuses on leading impurities development, testing, and regulatory supporting activities within the Analytical Operations department. Responsibilities
Provide leadership to a group of scientists focused on impurities and compendial method development and testing and product understanding. Mentor and guide scientists; 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 impurity strategies. Support design/justification/execution of end-to-end control strategy development and product quality targets. Deliver high-quality work packages for supporting Pivotal INDs and marketing applications. Serve as analytical development lead or analytical project lead for late-phase programs. Author and review CMC sections in regulatory filings; support interactions with health agencies. Collaborate 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. Be a key member of the extended Analytical Development leadership team to shape late-stage development strategies. Recruit, hire, and mentor talent to cultivate a world-class Biologics AD organization. Basic Qualifications
8+ years with BS degree 6+ years with MS degree 2+ years with PhD/PharmD 0+ years with MD Preferred Qualifications
PhD in Chemistry or related discipline with at least 3 years industry experience, or BS/MS with extensive industry experience. Significant expertise in HCP, host cell DNA, and other process impurity method development (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. Proven track record in drafting regulatory documentation (IND, BLA, PAS). Demonstrated ability to build strong collaborations with CMC functions. Strong business acumen; ability to balance resources, budget, and milestones. Leadership: collaboration, building high-performing teams, accountability, cross-functional engagement, program management, strategic vision, executive presence. People Leader Accountabilities
Create inclusion; model inclusion and embed diversity in management. Develop talent; coach employees on performance and potential, provide feedback for growth. Empower teams; align goals and remove barriers to connect teams to the broader ecosystem. Salary and Benefits
Salary ranges vary by location: Other US Locations $153,935.00 - $199,210.00; Bay Area $169,320.00 - $219,120.00. Compensation includes base salary, discretionary bonus, stock-based incentives, PTO, and benefits (medical, dental, vision, life insurance). Benefits information available at Gilead Careers site. Additional Information
Gilead is an equal opportunity employer; information about rights and accommodations is provided in the company policy. Employees may apply via the Internal Career Opportunities portal in Workday for current employees and contractors.
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