Associate Scientist, Purification Development

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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 against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

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Job Description
 

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

The Associate Scientist, Purification Process Development (Pivotal and Commercial) role will contribute to 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.

Key Responsibilities:

• Plan and execute experiments supporting process definition, characterization and troubleshooting of drug substance manufacturing unit operations such as centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal with limited supervision

• Mentor research associates in the initiation and execution of laboratory experimentation, considering appropriate safety, economic and regulatory factors.

• Ensure high-quality documentation in electronic laboratory notebooks and reports.

• Author and review 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 and 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.

Qualifications/Skills/Experience:

• M.S. with 3+ years OR B.S. with 5+ years 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, technical writing, and presentation skills and aptitude for creative problem solving.

• Experience writing CMC sections of commercial regulatory filings (BLA, MAA) and post approval change filings is a plus.

• Demonstrated ability to collaborate and influence cross-functionally.

• Familiarity with statistics, design-of-experiments, and data analysis