Site Manager Cell and Gene Therapy (CGT)
Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 8, 2021
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
Experience with programs from early development stages to
Experience with negotiating Cell and Gene Therapy contracts with
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
Keywords: Hoffmann-La Roche Ltd, South San Francisco , Site Manager Cell and Gene Therapy (CGT), Other , South San Francisco, California
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