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Scientist, Biologics CMC Analytical Development

Gilead SciencesGilead Sciences·Biopharmaceuticals

Compensation

$146,540 - $189,640/year

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About the role

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 teams. 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 PrePivotal 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 Toxicology 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 technologies (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 stateoftheart 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 CrossFunctionally 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. 

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. 

  • Proven experience leading early-stage CMC analytical programs, supporting pre-pivotal development (Toxicology, 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.

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Aplyr's read

Gilead Sciences is a leader in antiviral drug development, attracting professionals committed to advancing treatments for HIV, hepatitis, and other critical diseases.

Synthesized from recent postings & public sources

What's promising

  • Strong focus on antiviral drugs with a proven track record in HIV and hepatitis treatment.
  • Recent expansion into oncology and cell therapy indicates growth and diversification.
  • Robust pipeline of innovative medicines addressing unmet medical needs.

What to watch

  • High dependency on a few blockbuster drugs for revenue.
  • Regulatory challenges and pricing pressures in the pharmaceutical industry.
  • Potential for increased competition in the antiviral drug market.

Why Gilead Sciences

  • Pioneering role in developing antiviral therapies, particularly for HIV and hepatitis.
  • Integration of advanced technologies in research, such as AI for drug discovery.
  • Strategic expansion into oncology and cell therapy through acquisitions like Kite Pharma.

Aplyr’s read is generated by AI from public sources. Was it useful?

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About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need, with a focus on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza.

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