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Job Description
 

Principal Scientist in Biologics Analytical Development (Pivotal and Commercial).

United States - California – Oceanside, CA

This role will eventually move to Foster City

Job Description:

The Analytical Operations department is seeking a highly motivated Principal Scientist to lead our rapid testing team.  The ideal candidate must possess strong leadership skills to drive the implementation, testing, and iterative improvements for rapid testing, which spans physicochemical, compendial and plate based assays.  A strong understanding of regulatory expectations, risk assessment, and the role of rapid testing in biopharmaceutical development is essential. The candidate should be adept at troubleshooting complex assays, interpreting data, and driving innovation in rapid testing to support process development and product characterization.

 
Responsibilities: 

• Lead a high-throughput testing group to support process development across a wide range of analytical techniques: Chromatographic (SEC, CEX, RPHPLC, HILIC), electrophoretic (CE-SDS, icIEF) and compendial methods (pH, Osmo, subvisible particles, color etc). 

• • Manage routine process development and process characterization requests

  • Produce high quality, traceable results (ALCOA) for project team process development

  • Maintain required personnel to support testing, either via internal hires or through in-source contracting models.

  • Implement new technologies to improve throughput/quality of data

  • Implement agility and refinement of submission processes to achieve lean data packages for rapid decision making.

• Implementing rapid testing capabilities at Gilead Foster City site.  The implementation will include instrument set-up/qualification, sample submission process set-up, and personnel hiring/training.

• Maintaining and managing testing across applicable sites.

• Accountable for:

• • Defining and managing rapid testing strategies to support process development and process characterization studies, including documentation of data and IQ/OQ commensurate with the level of the data use (e.g. data used to set GMP specifications)

  • Driving continuous improvement of rapid testing to increase throughput and quality of data

  • Support the design/justification/execution of how rapid testing data supports the end-to-end control strategy development through a proactive definition of the product quality targets.

  • Delivering high quality work packages for supporting Pivotal INDa and marketing applications.

• Serve as an analytical project lead for late-phase program overseeing all analytical deliverables.

• Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies.

• Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful comm