Senior Manager, Technical Services – Purification

Job Description

Senior Manager, Technical Services – Purification

Gilead Sciences has an opportunity for an experienced candidate in the Drug Substance Process Development organization. We are seeking a motivated, team-oriented individual with expertise in purification operations and technical transfer of recombinant protein purification processes. Reporting to the Associate Director of Technical Operations, a Senior Manager for Biologics Technical Operations will support biologics manufacturing at our Oceanside, CA location as well as manufacturing campaigns at contract manufacturing organizations (CMOs).

Specific Job Responsibilities

• Lead Downstream Biologics Technical Operations team. Oversee personnel development and work with the head of BTO to provide strategic direction for technical operations and ensure that stakeholder needs are met.
• Lead internal Downstream New Product Introductions including; Facility Fit evaluation and Site-Specific Process Description authoring, Master Batch Record review/approval, Change Management ownership, review/approval of equipment automation updates, deviation resolution
• Provide continuous technical support on the production floor during manufacturing campaigns.
• Provide technical expertise in Downstream/purification technical transfers through an in-depth understanding of scale-up, engineering principles and associated equipment including; chromatography operations, tangential flow filtration, virus retentive filtration, vessel design and geometry, and Drug Substance filtration.
• Support and lead Gilead biologics Downstream technical operations by enabling timely and successful technology transfer of downstream 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
• Lead cross-functional teams which include stakeholders from Gilead’s Biologics Manufacturing, Process Development, Engineering, Supply Chain and Quality departments to provide routine Technology Transfer progress updates for 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.
• Serve as a subject matter expert during purification operations; provide technical troubleshooting and investigative support during internal and external manufacturing runs.
• 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
• Please note: role will require a minimum of 20% travel, locally and abroad.

Knowledge & Skills

• 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 and complex problems, projects, and assignments where analysis of data, procedures, or operations requires evaluation of multiple factors before acting.
• Must be able to work effectively in cross-functional teams.
• Must demonstrate excellent technical writing skills.

Education & Experience

• A Bachelor’s Degree and a minimum of eight (8) years of experience in a relevant scientific discipline, OR a Master’s Degree and a minimum of six (6) years of experience in a relevant scientific discipline, OR a PhD and a minimum of five (5) years of relevant experience in a relevant scientific discipline.
• Prior experience in a Downstream Technical Operations/MSAT role including technology transfer of biologics to contract manufacturing sites.
• In-depth understanding of cGMP requirements for commercial manufacturing, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections.
• Knowledge of cGMPs and validation requirements in all clinical phases.
• Experience with monoclonal antibody purification production including equipment and operations from thaw through harvest.
• Leverage technical expertise to lead investigations/author reports to support close-out of deviations and troubleshoot process excursions/issues for purification operations.

Preferred Experience

• Biologics experience with alternative modalities, expression systems, antibody design variants, and/or viral vaccines is a plus.

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

About Gilead

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.