Senior Research Scientist II, Purification Process Development – Pivotal & Commercial Biologics

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Job Description
 

Senior Research Scientist II, Purification Process Development – Pivotal & Commercial Biologics

*At a future date this position will relocate to the Gilead corporate HQ in Foster City, CA 

The Senior Research Scientist II, Purification Process Development (Pivotal and Commercial) will be responsible for leading all aspects of purification development including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. He/she will also lead projects for purification process technology development, platform process evolution, and related regulatory documentation.

Key Responsibilities:

• Hands-on technical leadership for the development, characterization, tech transfer and GMP manufacturing support of pivotal and commercial biologic purification processes.
• Manage and mentor research associates and members of project teams in the initiation and execution of laboratory experimentation, considering appropriate safety, economic and regulatory factors.
• Evaluate external service providers and oversee development activities.
• Ensure high-quality documentation in electronic laboratory notebooks and reports.
• Author, review, and approve development reports, process descriptions, batch records, regulatory filings, and process validation and characterization reports. The candidate must demonstrate excellent verbal and technical writing skills.
• Represent the Pivotal and Commercial Purification Development Department on product development/CMC teams.
• Lead and/or participate on cross-functional initiatives.
• Support investigations and identify root causes for critical deviations.
• Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
• Contribute to business process improvements related to pivotal/commercial process development.

Qualifications/Skills/Experience:

• Ph.D. with 5+ years OR M.S. with 10+ years OR 12+ Years with BS experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
• Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal is required.
• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities. Antibody drug conjugate experience is a plus.
• Excellent communication, technica