Scientist, Analytical Ops

Gilead Sciences; Foster City (CA); On-site; USD 146,000 - 190,000; Full time

Job summary

A biopharmaceutical company in Foster City is seeking a Scientist for its Analytical Development group. This role involves leading analytical characterization of biologic molecules and development of advanced methods with LC-MS technologies. Candidates should have a Ph.D. with relevant experience or an M.S. with extensive industry experience. This full-time position offers a salary range of $146,540.00 – $189,640.00, with additional benefits including health plans.

Benefits

Health insurance

Annual bonus eligibility

Stock-based incentives

Qualifications

• Ph.D. with 3+ years or M.S. with 6+ years in industrial biologics analytical development.
• Hands-on experience with LC-MS based biologics characterization.
• Familiarity with FDA/ICH guidelines.

Responsibilities

• Lead analytical characterization activities for biologic molecules.
• Develop advanced characterization methods using LC-MS technologies.
• Ensure compliance and integrity from testing organizations.

Skills

Analytical Chemistry

LC-MS characterization

Collaboration

Data analysis

Education

Ph.D. in Analytical Chemistry or related field

M.S. with relevant experience

Tools

HPLC

CE-SDS

Automated lab systems

Job description

Scientist, Analytical Ops – Foster City, CA

United States – Foster City – Process/Product Development & Operations – Regular

Company Introduction

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 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.

Job Overview

Gilead Sciences (Foster City, CA) is seeking a talented and highly motivated Scientist to join our 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/representative on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he 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 and support analytical characterization activities for pre‑pivotal (Toxicology, Phase I/II) biologic molecules. Identify molecule critical quality attributes, propose and justify analytical control strategies, and author relevant regulatory filings for biologic drug substance and drug product.
• Lead the development of advanced extended characterization methods utilizing state‑of‑the‑art mass spectrometry technologies, including (but not limited to) Native LC‑MS, CE‑MS, MD‑LC‑MS, affinity LC‑MS, and automated high‑throughput LC‑MS/MS, for pre‑pivotal (Phase I/II) biologics.
• Develop analytical methods to be used for molecule characterization and/or release testing (using HPLC‑UV, CE, HPLC‑FLR, iCIEF, HPLC‑CAD, etc.). Author associated method development reports, test procedures, validation protocols, and reports.
• Proactively evaluate and implement state‑of‑the‑art technologies to drive innovation in analytical development and testing.
• Oversee and advise data generation/data integrity, and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.
• Maintain strong relationships with key stakeholder functions and work cross‑functionally with colleagues in Research, Clinical Development, Clinical Supply Management, and Program Strategy teams by providing technical and strategic input.
• Provide technical support to internal and external cGMP manufacturing operations.
• Present research findings and recommendations to senior staff, prepare research reports and peer‑reviewed manuscripts, and contribute to the preparation of INDs and patent filings.

Qualifications

• Ph.D. with 3+ years of experience or M.S. with 6+ years in Analytical Chemistry or related fields, with industrial experience in biologics analytical development.
• Advanced expertise and hands‑on experience with LC‑MS‑based biologics characterization and data analysis to support CMC process development.
• Experience with analytical method development, validation, and control strategies of biologic products (e.g., HPLC, CE‑SDS, iCIEF, LC‑MS/MS, intact/reduced/sub‑units mass, gel electrophoresis, etc.).
• Familiarity with FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.
• Ability to build strong collaborations with other CMC functions.
• Working knowledge of lab automation, computer validation, data governance, data science, knowledge management, and data protection.
• Ability to create inclusion – knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage teams.

Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

Compensation & Benefits

Salary range: $146,540.00 – $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. Actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary by 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.

Equal Employment Opportunity

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 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 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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

Legal & Employment Policies

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT – YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Internal Applicants

Please apply via the Internal Career Opportunities portal in Workday.

Job Details

Job Requisition ID: R0048995

Job Level: Manager

Location: Foster City, CA (Onsite)

Job Type: Full Time