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United States - California - Foster City, United States of America
Onsite
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
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.
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.
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Please apply via the Internal Career Opportunities portal in Workday.