Gilead Sciences
Principal Scientist in Biologics Analytical Development (Pivotal and Commercial)
Gilead Sciences, San Francisco, California, United States, 94199
Principal Scientist in Biologics Analytical Development (Pivotal and Commercial).
Base pay range: $195,670.00/yr - $253,220.00/yr Gilead Sciences is focused on creating a healthier world. We seek a talented and highly motivated Principal Scientist for our Pivotal and Commercial Biologics Characterization team in Biologics Pivotal and Commercial Analytical Development. Broad experience in analytical development from early development to commercial launch, filing experience with FDA/EMA, and in-depth technology understanding for biological products are the key requirements. A solid understanding of GMPs and CMC requirements is expected. Responsibilities
Provide leadership to a group of scientists focused on excipient / process reagent methods and product understanding. Mentor and guide scientists in their roles. Set clear expectations and prioritize work packages. Recruit and hire new talent. Define excipient and process reagent testing and control strategies across the late-phase biologics portfolio and build deep understanding of how this relates to product stability. Drive continuous improvement of excipient strategies. Support the design/justification/execution of end-to-end control strategy development through proactive definition of product quality targets. Deliver high-quality work packages supporting Pivotal INDs and marketing applications. Serve as an analytical project lead (ASTL) for late-phase programs overseeing all analytical deliverables. Author and review CMC sections in regulatory filings and support interactions with health agencies. Collaborate across Gilead 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. Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standards, comparability, and specifications. Drive adoption of novel and state-of-the-art characterization technologies and approaches. Recruit, hire, and mentor talent to help cultivate a world-class Biologics AD organization. Specific Education
3+ years of experience and PhD in Chemistry. Or BS or MS degree with extensive industry experience. Specific Job Responsibilities
Conduct scientific research for the development of drug candidates or the research support of marketed drugs. Apply analytical chemistry principles to products and problems. Collaborate with more senior scientists or scientific directors to advance state-of-the-art techniques to characterize substances, assays and tools. Address moderately complex problems requiring evaluation of variables, often with ingenuity and creativity. Advise Research Associates or project teams in initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors. Present results, interpret data, and draw conclusions about the work. Maintain knowledge of state-of-the-art principles and apply them to support company interests. Demonstrate technical proficiency, scientific creativity, collaboration, and independent thought in experimental design and strategy. Think critically and creatively, work independently, identify resources, and plan effectively. People Leader Accountabilities
Create Inclusion – value diverse teams and embed inclusion in management. Develop Talent – understand skills and potential and coach for growth and future opportunities. Empower Teams – align goals with organizational objectives and remove barriers. Excellent verbal and interpersonal communication skills. The salary range for this position is: $195,670.00 - $253,220.00. Compensation includes base pay, discretionary bonus, stock-based incentives, paid time off, 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 Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and fostering an inclusive work environment with diverse perspectives, backgrounds, and experiences. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other non-job related characteristics in accordance with applicable laws. Reasonable accommodations in the application process may be requested by contacting ApplicantAccommodations@gilead.com. Additional Information
For current Gilead employees and contractors, please apply via the Internal Career Opportunities portal in Workday.
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Base pay range: $195,670.00/yr - $253,220.00/yr Gilead Sciences is focused on creating a healthier world. We seek a talented and highly motivated Principal Scientist for our Pivotal and Commercial Biologics Characterization team in Biologics Pivotal and Commercial Analytical Development. Broad experience in analytical development from early development to commercial launch, filing experience with FDA/EMA, and in-depth technology understanding for biological products are the key requirements. A solid understanding of GMPs and CMC requirements is expected. Responsibilities
Provide leadership to a group of scientists focused on excipient / process reagent methods and product understanding. Mentor and guide scientists in their roles. Set clear expectations and prioritize work packages. Recruit and hire new talent. Define excipient and process reagent testing and control strategies across the late-phase biologics portfolio and build deep understanding of how this relates to product stability. Drive continuous improvement of excipient strategies. Support the design/justification/execution of end-to-end control strategy development through proactive definition of product quality targets. Deliver high-quality work packages supporting Pivotal INDs and marketing applications. Serve as an analytical project lead (ASTL) for late-phase programs overseeing all analytical deliverables. Author and review CMC sections in regulatory filings and support interactions with health agencies. Collaborate across Gilead 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. Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standards, comparability, and specifications. Drive adoption of novel and state-of-the-art characterization technologies and approaches. Recruit, hire, and mentor talent to help cultivate a world-class Biologics AD organization. Specific Education
3+ years of experience and PhD in Chemistry. Or BS or MS degree with extensive industry experience. Specific Job Responsibilities
Conduct scientific research for the development of drug candidates or the research support of marketed drugs. Apply analytical chemistry principles to products and problems. Collaborate with more senior scientists or scientific directors to advance state-of-the-art techniques to characterize substances, assays and tools. Address moderately complex problems requiring evaluation of variables, often with ingenuity and creativity. Advise Research Associates or project teams in initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors. Present results, interpret data, and draw conclusions about the work. Maintain knowledge of state-of-the-art principles and apply them to support company interests. Demonstrate technical proficiency, scientific creativity, collaboration, and independent thought in experimental design and strategy. Think critically and creatively, work independently, identify resources, and plan effectively. People Leader Accountabilities
Create Inclusion – value diverse teams and embed inclusion in management. Develop Talent – understand skills and potential and coach for growth and future opportunities. Empower Teams – align goals with organizational objectives and remove barriers. Excellent verbal and interpersonal communication skills. The salary range for this position is: $195,670.00 - $253,220.00. Compensation includes base pay, discretionary bonus, stock-based incentives, paid time off, 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 Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and fostering an inclusive work environment with diverse perspectives, backgrounds, and experiences. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other non-job related characteristics in accordance with applicable laws. Reasonable accommodations in the application process may be requested by contacting ApplicantAccommodations@gilead.com. Additional Information
For current Gilead employees and contractors, please apply via the Internal Career Opportunities portal in Workday.
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