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Site Manager Cell and Gene Therapy (CGT)

Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 8, 2021

Job Description:

The Drug Product External Manufacturing organization runs the manufacturing and packaging of sterile and solids drug product (DP) across contract manufacturing organizations (CMOs), primarily in Europe and North America.

The Cell and Gene Therapy (CGT) Site Manager is responsible for leading a cross-functional team during a Contract Manufacturing Organization (CMO) life cycle phases (i.e. selection, implement/manage and decommissioning) at one or more CMOs, primarily in North America and Europe. The CGT CMO Site Manager is leading and/or overseeing transfers and launches at the respective CMO(s), which might include Drug Substance, Drug Product, labelling and cryopreservation manufacturing steps. The Site Manager acts as the primary contact with the specified CMO(s) for the entire relationship. The Site Manager is accountable for all operational CMO activities: assure product development, manage budget and oversee clinicalcommercial manufacturing including monitoring of the CMO's performance and risk mitigation activities. The Site Manager will lead cross-functional joint project teams (JPT) for development programs and joint management teams (JMT) for commercial products responsible for GMP, quality and compliance standards for the relevant CMOs and accountable for monitoring quality, compliance and regulatory aspects.

Requirements & Qualifications:

  • 8+ years' experience successfully working in an operations environment, with at least 5 years of managing large, complex cross-functional projects from Drug Substance to Drug Product.

  • BS in the relevant Engineering or Life Sciences field discipline is required. An advanced degree (MBA, MS, or PhD) desired.

  • Experience of working with Contract Manufacturers desired.

  • Strong technical knowledge and special expertise in either cell therapy, gene therapy andor virus vector manufacturing in a GMP-regulated environment.

  • Experience with programs from early development stages to launch.

  • Experience with negotiating Cell and Gene Therapy contracts with CDMOs.

  • Strong cross-functional leadership skills and the ability to collaborate and communicate at different hierarchy levels

  • Certification in Project Management (e.g. PMI) or additional relevant management training is a plus.

  • Certified/expertise in improvement or problem solving methodologies (Six Sigma, Lean, RCA) is a plus.

  • The position may require up to 25% domestic and international travel.

Keywords: Hoffmann-La Roche Ltd, South San Francisco , Site Manager Cell and Gene Therapy (CGT), Other , South San Francisco, California

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