Scientist, Biologics CMC Analytical Development

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   Scientist, Biologics CMC Analytical Development   Gilead Sciences (Foster City, CA) is   seeking   a talented and highly motivated   Scientist to join our   PDM   Pre-Pivotal Biologics Analytical   Development   group. Our collaborative and interdisciplinary   development   team   utilizes   state-of-the-art   technologies and innovative methodologies to advance medicines into the clinic. The successful candidate is expected to   serve as the analytical   lead   on   PDM (Pharmaceutical Development & Manufacturing) project team s . You will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.   Responsibilities:    Lead   CMC   Analytical   Team   for   Pre ‑ Pivotal   Biologics   Serve as the   CMC   analytical   sub-team   lead to define potential critical quality attributes ( pCQAs ),   establish   phase-appropriate   control strategies, and enable characterization of biologics supporting   T oxicology and early clinical development (Phase I/II).   Drive Analytical Method Development & Implementation   Design, develop, and deploy robust analytical methods for product characterization and release/stability testing using advanced   technologie s ( e.g.,   HPLC-UV/FLR/CAD/ELSD, CE/ iCIEF ,   Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS ). Author method development reports, test procedures, and associated technical documentation.   Advance Innovation in Analytical Development   Evaluate and implement   state ‑ of ‑ the ‑ art   technologies and emerging approaches to enhance analytical capabilities, improve efficiency, and enable deeper molecular understanding.   Ensure Data Integrity and Operational Excellence   Provide technical oversight of internal and external analytical activities, ensuring high-quality data generation, compliance with regulatory expectations, and strong data governance across CRO /CDMO   partnerships.   Collaborate   Cross ‑ Functionally   to Drive Program Success   Partner closely with Research, Process Development, Clinical Development,   Safety , and Program Strategy teams to provide strategic and technical input across the product lifecycle.   Contribute to Regulatory and Scientific Deliverables   Present findings to senior leadership, author technical   reports   and manuscripts, and support regulatory submissions ( e.g.,   IND /IMPD/CTA ) and intellectual property filings.   Basic Qualifications:    Ph.D. with   3 + years or M.S. with   6 + years in Analytical Chemistry or related fields ,   with a focus on biologics   (therapeutic proteins)   CMC   analytical development.   Preferred Qualifications Proven   exp erience   l ead ing   early-stage CMC analytical programs, supporting pre-pivotal development ( T oxicology, Phase I/II) and regulatory submissions (IND/IMPD).   Strong experience in analytical method development,   qualification/ validation, and control strategy for biologics (e.g., HPLC,   iCIEF ,   CE ,   LC‑MS based biologics characterization and data analysis ).   Working knowledge of FDA/ICH regulatory expectations for drug substance and drug product quality and compliance.     Demonstrated ability to collaborate effectively across CMC and cross‑functional teams.   Familiarity with digital and data capabilities, including lab automation, data governance, computer system validation, and knowledge management.   Commitment to fostering inclusive, high‑performing teams, recognizing the value of diverse   perspectives. Gilead Core Values   Integrity (Doing What’s Right)   Inclusion (Encouraging Diversity)   Teamwork (Working Together)   Excellence (Being Your Best)   Accountability (Taking Personal   Responsibility)      The salary range for this position is: $146,540.00 - $189,640.00. 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: 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. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT 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.   Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.