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Director, Analytical Development and Quality
2 months ago
We are seeking a highly experienced and skilled Executive Director to lead our Analytical Development team at Gilead Sciences, Inc. This is a critical role that will play a key part in shaping the future of our biologics portfolio.
Key Responsibilities- Provide strategic leadership to the Analytical Development team, driving the development of analytical methods, control strategies, and regulatory strategies for drug substance and drug product quality attributes.
- Develop and implement comprehensive product quality control strategies for biopharmaceutical processes, ensuring compliance with industry best practices and regulatory requirements.
- Collaborate with cross-functional teams, including Research, Clinical Development, and Product Strategy, to ensure timely delivery and successful commercialization of late-stage portfolio.
- Recruit, mentor, and nurture talent to cultivate a world-class Biologics AD organization, fostering a culture of excellence and innovation.
- Oversee departmental budgeting and ensure effective resource allocation to drive business objectives.
- Ph.D. or M.S. in a relevant field with 15+ years of experience in analytical development, showcasing increasing responsibility and comprehensive experience managing programs from INDs to MAAs.
- Subject matter expert in MOA for defining CQAs and QbD-based control strategies, comprehensive product quality control strategies for biopharmaceutical processes, and development/qualification/validation of various assays.
- Well-acquainted with industry best practices, guidelines, and trends, with a proven track record in drafting regulatory documentation of all stages, including IND, BLA, and MAA filings.
- Effective team builder with proven leadership in a multidisciplinary setting, outstanding communication, decision-making, and interpersonal skills.
- Demonstrated ability to influence and shape industry standards with a notable presence in the scientific community.
Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. We are committed to making a difference in the lives of people around the world by advancing the care of patients with life-threatening diseases.
What We Offer- Competitive salary range: $274,000 - $355,000
- Discretionary annual bonus and stock-based long-term incentives
- Paid time off and a comprehensive benefits package
