Senior Director/Vice President, CMC

4 days ago

Cambridge, Massachusetts, United States Repertoire Immune Medicines Full time
Job Description

We are seeking a highly experienced and skilled Senior Director/Vice President, CMC to join our team at Repertoire Immune Medicines. This is a unique opportunity to lead our CMC efforts and contribute to the development of novel targeted immune medicines.

Key Responsibilities
  • Build and lead effective CMC Teams to develop and optimize upstream and downstream processes to generate lead and Development Candidate protein biologics.
  • Provide CMC expertise and guidance to inform Development Candidate nomination.
  • Identify Contract Development and Manufacturing Organizations (CDMOs), develop contracts in conjunction with Executive Leadership and Finance.
  • Transfer manufacturing processes to CDMOs and manage CDMO activities from candidate nomination through process development, analytical development, and early phase clinical manufacturing to ensure on-time delivery of material for IND enabling and clinical studies.
  • Transfer analytical methods to external Contract Research Organizations (CROs)/CDMOs and provide additional training, troubleshooting, or technical support, as necessary.
  • Manage analytical and stability programs at CROs.
  • Author and review technical documents and reports for inclusion in CMC sections of regulatory filings.
  • Develop goals, operating plans, production milestones, and short and long-term objectives for all CDMO/CRO contracts.
  • Proactively identify opportunities to accelerate manufacturing to enable clinical start in a compressed timeline.
Requirements
  • PhD degree in Biochemistry, Biology, Bioengineering, Immunology, or a similar field.
  • 15 plus years' experience in pharma/biotech industry with significant management experience in upstream/downstream process development and manufacturing of protein therapeutics.
  • Experience with Tech transfer to CDMO for non-GMP and GMP manufacturing, including cell line development, process development, analytical method development and manufacturing scale up.
  • Experience in research strategy development and operational management of research outcomes through cross-functional and outsourced teams, as well as budget planning and management.
  • Well-developed understanding of all aspects of drug development with includes direct experience in working with research and clinical organizations.
  • Creates breakthrough approaches within and across functions, if appropriate, to meet stretch goals impacting company direction.
  • Desirable to have experience with bispecific protein products.
  • Technical report writing for inclusion in regulatory submissions.
  • Proven and extensive leadership and people management skills with the ability to work cross-functionally and communicate effectively across functional areas.
  • Ability to drive strategic discussions with senior level management and external partners.
  • Domestic and International travel required to support management of CDMOs.

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