Director, Biotherapeutics Development, CMC
Company: GQR Global Markets
Location: Redwood City
Posted on: May 9, 2022
The Associate Director / Director, Biotherapeutics
Development/CMC role is critical to the success of pharmaceutical
development and manufacturing efforts in pre-clinical and early
stage clinical drug substance and drug product development for
self-developed enzyme therapeutics pipeline. Working very closely
with technical project teams and the operational and quality
functions, as well as with consultants as appropriate, this project
leader role will be key to the successful technical and operational
management of biotherapeutics development programs.
Coordination of multi-functional development teams including
research, translational biology, bioprocess development, analytical
development, quality, formulation, toxicology and regulatory
resources in order to efficiently execute against development goals
and identify opportunities for acceleration of timelines.
Building and managing project budgets including review of invoices
and amending budget, revenue and expense forecasts.
Critical involvement in identification and selection of CRO and
CDMO partners for outsourced development and manufacture of drug
substance and drug product through development of business
intelligence on potential CRO and CDMO partners, preparation of
RFPs, review of proposals, and participation in contract
Management of CRO and CDMO relationships in order to achieve the
successful completion of project specific activities and timely
achievement of project milestones.
Management of the identification, calibration, mitigation and
escalation of risks in the development, technology transfer and
scale-up of drug substance and drug product at biotherapeutic
Ensuring timely completion of IND-enabling studies and preparation
of the CMC sections of regulatory submissions (IND or other) for
Phase 1 clinical studies.
The ability to resolve time critical technical issues is assumed
but consider some additional description of "Responsibility for
resolution of difficult, time critical and detailed project
obstacles." There is never a project without the pressure cooker
high stress moments - we need an individual
Minimum of either a PhD with 5 years of experience or MS with 10
years of experience or a BS/BA (in biochemistry, chemistry,
bioengineering or a related discipline) with 15+ years of
experience in CMC related biologics development roles in an
industrial environment. GMP experience strongly preferred.
Drug substance development experience with biotherapeutic molecules
essential and drug product development experience preferred.
Knowledge of enzymes desired.
Experience with a range of biologic manufacturing expression
systems desired - ideally including both microbial and mammalian
Experience managing external CRO/CDMO/CMO relationships required,
ideally including demonstrated experience running vendor selection
processes and contract/scope negotiations.
Experience preparing and supporting early phase regulatory filings
strongly preferred - IND strongly preferred and knowledge of
regulatory submission in other geographies desired.
Excellent communication skills (written and verbal)
Strong project leadership experience and skills
Expertise in using MS Office, including MS Project, essential
Must be able to travel internationally and domestically a minimum
of 10% of the time
Keywords: GQR Global Markets, Redwood City , Director, Biotherapeutics Development, CMC, Executive , Redwood City, California
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