Senior Associate II, Tech Services - Downstream
Senior Associate II/Technical Services – Purification
Gilead has an opportunity for an experienced candidate in Biologics Drug Substance Development at our Oceanside facility in Southern California. We are seeking a motivated, team-oriented individual with expertise in purification/downstream operations and technical transfer of recombinant proteins. Reporting to a Sr Associate Scientist in Biologics Technical Operations, you will have the opportunity to participate in technology transfer of monoclonal antibody cell culture processes to internal and external manufacturing sites.
- Support internal Downstream New Product Introductions including; Facility Fit evaluation, Site-Specific Process Description authoring, Master Batch Record review/approval, Change Management ownership, review/approval of Automation updates, deviation resolution as well as providing continuous technical support on the production floor during manufacturing campaigns
- Support Gilead biologics purification technical operations by enabling timely and successful technology transfer of upstream manufacturing processes to external Contract Manufacturing Organizations (CMOs)
- Ensure that appropriate process data are recorded and analyzed to monitor run-to-run consistency for Downstream operations across internal and CMO production campaigns
- Work closely with Gilead's Biologics Quality and Operations teams and provide routine Technology Transfer progress updates to internal and external technical teams.
- Collaborate with Gilead's Biologics Outsourcing group to ensure timelines, deliverables, and business operations are aligned and met in accordance with the Technology Transfer of molecules to CMOs.
- 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 equipment or technologies internally and at CMOs
- Support and drive yield improvements and process efficiencies
- Contribute and/or lead cross-functional projects with limited direction
Knowledge & Skills
- Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs).
- Demonstrates excellent verbal, written and interpersonal communication.
- Able to work effectively in cross-functional teams.
- Demonstrates excellent technical writing skills.
- Works on non-routine to somewhat complex problems, projects, and assignments where analysis of data, procedures or operations requires evaluation of multiple factors before acting.
Education & Experience
- A Bachelor's Degree in a relevant scientific discipline and a minimum of six (6) years of experience OR a Master's Degree in a relevant scientific discipline with a minimum of five (5) years of experience.
- Understanding of cGMP requirements for clinical and commercial manufacturing, data capture/management and process monitoring/trending.
- Experience with monoclonal antibody purification production including equipment and operations, including chromatography, virus retentive filtration, and tangential flow filtration.
- Biologics experience with alternative modalities, expression systems, antibody design variants, and/or viral vaccines.
- Process validation and Process Performance Qualification (PPQ)
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: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes 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.
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