Responsibilities
Lead, mentor, and develop a team of scientists that define end-to-end analytical development strategies (from raw materials through drug product) for Gilead portfolio across pre-clinical, all clinical phases and commercial lifecycle. The control strategies include impurity control (process impurities, degradants, mutagenic impurities per ICH M7, nitrosamines, elemental impurities per ICH Q3D)
Partner with Research, Regulatory Affairs, Process Chemistry, Formulation, Quality, and Manufacturing to align control strategies with process & product understanding and regulatory expectations
Drive the development, implementation, and continuous improvement of analytical methodologies and technologies including HPLC/UPLC, GC, dissolution, KF, spectroscopy, particle size, etc. aligned with ICH guidelines and phase-appropriate development needs
Guide technical transfer to internal QC laboratories and support method development/technical transfer to external partners (CDMOs/CTLs)
Direct development stability strategy and support GMP stability programs (ICH Q1A–Q1E), including shelf-life setting and stability data interpretation
Champion modern approaches including analytical QbD (ICH Q14), enhanced method development, and data integrity best practices
Direct innovation of analytical technologies to improve productivity and increase product and process understanding
Serve as cross-functional team leader. Participate in governance and technical review committees; contribute to portfolio-level CMC strategy and risk assessment
Author, review, and approve analytical sections of regulatory submissions (IND/IMPD, NDA/MAA, amendments, responses to health authority questions)
Represent Analytical Development in health authority interactions and pre-approval/pre-license inspections
Operate within departmental budget, resource allocation, and prioritization across a multi-program portfolio
Foster a culture of scientific rigor, quality, inclusion, and continuous improvement
Qualifications
Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline with 8+ years of relevant experience in pharmaceutical/biotech analytical development with Ph.D., 10+ years with MS and 12+ years with BS.
5+ years of people management experience, including directing managers and leading sizeable teams
Demonstrated expertise in small molecule analytical development and technology innovation across the full development lifecycle, including early and late-stage development & commercial support
Deep working knowledge of ICH guidelines (Q1, Q2, Q3, Q6A, Q14, M4, M7), cGMP requirements, and global regulatory expectations
Experience contributing to regulatory submissions (IND/CTA, NDA/MAA) and responding to questions to global health authorities
Strong cross-functional leadership, oral and written communication skills; able to influence at senior levels in a matrixed organization
Experience with complex dosage forms (e.g., API, fixed-dose combinations, modified release, sterile injectables) or specialized modalities
Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling/ simulation).
Experience with pre-approval inspections (PAI) and commercial lifecycle management (post-approval changes, ICH Q12)
Experience building or restructuring analytical organizations; including LIMS/ELN and digital lab initiatives
Demonstrated strategic thinking and portfolio prioritization; scientific judgment under ambiguity; talent development; stakeholder management; decision-making in cross-functional governance settings; written and verbal communication suitable for executive and regulatory audiences.
The salary range for this position is: $226,185.00 - $292,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States
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