Job Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As an Principal Scientist, Analytical Lifecycle Management , you will serve as the Quality Control lead for late-stage biologics programs, acting as the primary QC representative on cross-functional Chemistry, Manufacturing, and Controls (CMC) teams. This role is accountable for developing and driving integrated QC strategies throughout the product lifecycle. The position requires strong scientific and regulatory judgment, cross-functional influence, and the ability to translate complex QC topics into clear recommendations that support registration and commercialization readiness.
Analytical Lifecycle Management
Job Responsibilities:
- Serve as the QC Lead for late-stage clinical biologics programs, acting as the primary QC representative and accountable strategic point of contact on cross-functional CMC teams.
- Independently provide QC leadership, technical direction, and risk-based decision-making to advance biologics drug substance and drug product programs toward late-stage development, registration, and commercialization readiness.
- Own and drive integrated QC program strategy across analytical method establishment, qualification and validation, method transfer, specification setting, stability and shelf-life strategy, reference standard strategy, critical reagent planning, and overall analytical control strategy.
- Lead authorship, technical review, and strategic input for QC-related sections of regulatory submissions and health authority responses, ensuring scientific rigor, consistency with product strategy, and alignment with global GMP and regulatory expectations.
- Provide oversight of external partners, such as Contract Development and Manufacturing Organizations (CMDOs) and Contract Testing Laboratories (CTLs), including method readiness, testing execution, data quality, laboratory investigations, quality events, and alignment with program objectives.
- Anticipate, evaluate, and resolve complex technical, quality, and compliance issues where precedent may be limited, using sound scientific judgment, cross-functional influence, and risk-based decision-making.
- Influence strategic outcomes across functions by translating complex QC topics into clear recommendations, building alignment among senior stakeholders, and driving timely decisions in support of critical program milestones.
- Provide technical mentorship, coaching, and guidance to matrixed colleagues and program team members, fostering scientific rigor, accountability, collaboration, and high-quality execution of QC deliverables.
- Provide strategic oversight of laboratory-based activities as needed, including technical troubleshooting, method readiness assessments, testing strategy, and interpretation of data supporting program decisions.
Requirements:
- PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline and 5+ years of relevant experience; OR
- Master’s Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline and 8+ years of relevant experience; OR
- Bachelor’s Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline and 10+ years of relevant experience.
Preferred:
- Extensive experience in Quality Control, Analytical Development, or CMC technical roles supporting biologics drug substance and/or drug product programs in a GMP-regulated environment.
- Demonstrated experience leading or significantly contributing to late-stage biologics QC strategy, including analytical method establishment, qualification and validation, method transfer, specification setting, stability strategy, shelf-life justification, reference standards, and critical reagents.
- Strong understanding of global GMP expectations, ICH guidance, compendial requirements, and regulatory expectations applicable to biologics analytical control strategy and QC lifecycle management.
- Experience authoring, reviewing, or providing technical input to QC-related sections of regulatory submissions, health authority responses, comparability packages, or late-stage CMC documentation.
- Proven ability to influence cross-functional teams, communicate complex technical topics to senior stakeholders, drive alignment, and make sound, risk-based decisions in support of program milestones.
- Demonstrated ability to work independently in a matrixed environment, anticipate program risks, resolve complex technical and compliance issues, and provide strategic recommendations where precedent may be limited.
- Experience overseeing external partners such as CDMOs and CTLs.
- Excellent written and verbal communication skills, with the ability to mentor matrixed colleagues, represent QC perspectives clearly, and produce high-quality technical and regulatory documentation.
- Ability to speak and read Mandarin is preferred but not required.
People Leader Accountabilities:
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
