Research Scientist - Pre-Pivotal Biologics Analytical Operations

Key Skills

Automation, Effective communication skills

Job Description

Gilead Sciences (Foster City, CA) is seeking a talented and highly motivated Research Scientist 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 characterization activities for pre-pivotal (Phase I/II) biologic molecules. Identify molecule critical quality attributes, propose and justify analytical control strategies, author relevant regulatory filings for biologic drug substance and drug product. 
• Develop analytical methods to be used for molecule characterization and/or release 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.
• Proactively evaluate and implement state of the art technologies to drive innovation in Analytical Development 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. in a relevant scientific discipline or M.S. with 6+ years in Analytical Chemistry or related fields of industrial experience in biologics analytical development.
• Experience with analytical method development, validation, and control strategies of biologic products (e.g. HPLC, CE-SDS. iCIEF, LC-MS/MS, intact mass, gel electrophoresis, etc). 
• 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: $154,020.00 - $199,320.00. 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