Gilead Sciences, Inc. Sr Associate II, Biologics Technical Operations - Purification in Oceanside, California

For Current Gilead Employees and Contractors:

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Job Description

Gilead has an opportunity for an experienced candidate in Biologics Technical and Manufacturing Operations at our Oceanside facility in Southern California. We are seeking motivated, team oriented individuals with expertise in purification operations and technical transfer of recombinant proteins. Reporting to the Director of Technical Operations, you will have the opportunity to participate in technology transfer of monoclonal antibody purification processes to internal and external manufacturing sites.

Specific responsibilities and skills for Position:

  • Support Gilead biologics purification technical operations by enabling timely and successful technology transfer of downstream manufacturing processes to external partners (CMOs)

  • Perform facility fit assessments and identify process gaps and generate solutions to ensure successful process fit into internal and external manufacturing plants

  • Collaborate with the Process Development, Manufacturing, and Upstream Technical Operations to ensure successful technology transfer of biologic processes including evaluation of the automation and process control strategy, bill of materials, and master batch record drafting/review

  • Monitor and evaluate purification process performance data, report and present findings

  • Support and drive yield improvements and process efficiencies

  • Lead/coordinate cross-functional projects with limited direction

  • Independently plan and execute experiments in a pilot or laboratory setting in support of process optimization initiatives or manufacturing technical assessments

  • Apply knowledge of current Good Manufacturing Practices (cGMPs)

  • Contribute to and/or lead technical investigations of process deviations and assessment of impact on product quality

  • Identify areas for improvement or optimization, lead implementation of best practices, and present data to applicable departments on the outcome of investigations or optimization initiatives

  • Coordinate or support implementation of new technologies onsite and at CMOs.

  • Serve as a subject matter expert during purification operations; provide technical troubleshooting and investigative support during internal and external manufacturing runs.

Essential Duties and Job Functions:

  • Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs)

  • Demonstrates excellent verbal, written and interpersonal communication

  • Works on non-routine to somewhat complex problems, projects, and assignments where analysis of data, procedures or operations requires evaluation of multiple factors before taking action

Knowledge, Experience and Skills:

  • 5+ years of experience with BS degree in a relevant scientific discipline.

  • 3+ years of experience with MS degree in a relevant scientific discipline.

Preferred training and experience:

  • Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline

  • Prior experience in a Technical Operations/MSAT purification role including technology transfer of biologics to contract manufacturing sites

  • Knowledge of cGMPs and validation requirements in all clinical phases

  • Antibody experience is required. Familiarity with monoclonal antibody downstream platforms, centrifugation, chromatography, and filtration. Biologics experience with alternative modalities, expression systems, antibody design variants, and/or cell therapy is a plus

  • Must be able to work effectively in cross-functional teams

  • Must demonstrate excellent technical writing skills

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead