Scientist, Analytical Ops

Scientist, Analytical Ops

Gilead Sciences , Foster City, CA – Pre‑Pivotal Biologics Analytical Development group.

We are seeking a talented and highly motivated Scientist to serve as the analytical lead / representative on PDM (Pharmaceutical Development & Manufacturing) project teams. The successful candidate will lead and support analytical characterization activities for pre‑pivotal biologic molecules, develop advanced characterization methods with state‑of‑the‑art mass spectrometry technologies, develop analytical methods for release testing, evaluate new technologies, oversee data integrity, maintain stakeholder relationships, provide technical support to manufacturing operations, and present findings to senior staff.

Responsibilities

• Lead and support analytical characterization activities for pre‑pivotal (Toxicology, Phase I / II) biologic molecules; identify critical quality attributes, propose and justify analytical control strategies, author regulatory filings for drug substance and product.
• Lead development of advanced extended characterization methods utilizing Native LC‑MS, CE‑MS, MD‑LC‑MS, affinity LC‑MS, automated high‑throughput LC‑MS / MS for pre‑pivotal biologics.
• Develop analytical methods for molecule characterization and / or release testing (e.g., HPLC‑UV, CE, HPLC‑FLR, iCIEF, HPLC‑CAD). Author 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 Research, Clinical Development, Clinical Supply Management and Program Strategy Teams.
• 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; contribute to IND and patent filings.

Qualifications

Gilead Core Values

The salary range for this position is $146,540.00 – $189,640.00. This position may also be eligible for discretionary annual bonus, stock‑based long‑term incentives, paid time off and a benefits package that includes 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 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.

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

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