Senior Research Scientist I - Pre-Pivotal Biologics Analytical Operations

Description

Gilead Sciences (Foster City, CA) is seeking a talented and highly motivated Senior Research Scientist I to join our Pre-Pivotal Biologics Analytical Operations 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.

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 analytical development and product characterization activities for pre-pivotal (Phase I / II) biologic molecules.

Identify molecule potential critical quality attributes, propose and justify analytical control strategies, author relevant regulatory filings, and address Information Requests from Health Authorities for biologic drug substance and drug product.

• Lead LC-MS based extended characterization methods development and implementation
• Develop analytical methods to be used for product characterization and / or release / stability testing. Author associated method development reports, test procedures, validation protocols and reports.
• Oversee and advise data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.
• Lead potential analytical method transfer to contract organizations and ensure timely delivery of project milestones
• Proactively evaluate and implement state of the art technologies to drive innovation in Analytical Development, Operations and Testing.
• Maintain strong relationships with key stakeholder functions and work cross-functionally with colleagues in Research, Clinical Development, and Clinical Supply Management and Program Strategy Teams by providing technical and strategic input.
• Provide technical support to internal and external cGMP manufacturing operations.
• Presents 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 2+ years OR M.S. with 8+ years OR BS with 10+ years of experience in Analytical Chemistry or related fields of industrial experience in biologics analytical development.
• Extensive experience with LC-MS / MS based method development and biologics characterization
• Experience with analytical method development, qualification / validation, and control strategies of biologic products (e.

g. HPLC, CE-SDS. iCIEF, LC-MS, intact mass, ).

• Familiar with FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.
• Ability of building strong collaborations with other CMC functions.
• Working knowledge of lab automation, computer validation, data governance, data science, knowledge management and data protection.
• Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.

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 : $177,905.00 - $230,230.00. 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 :

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States :

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 for assistance.