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Director, Biotherapeutics Development, CMC

Company: GQR Global Markets
Location: Redwood City
Posted on: May 9, 2022

Job Description:

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 negotiations.
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 CDMOs.
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 strains.
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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