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Senior Vice President, CMC Operations

2 months ago

Cambridge, Massachusetts, United States Repertoire Immune Medicines Full time
Senior Vice President, CMC Operations

Repertoire Immune Medicines stands at the forefront of biotechnology, committed to leveraging the human immune system to address challenges in cancer, autoimmune disorders, and infectious diseases. Our cutting-edge DECODETM platform focuses on T cell receptor (TCR)-antigen immune synapses, paving the way for the creation of targeted immune therapies that aim to transform treatment methodologies.

In the capacity of a senior leader in CMC, you will be responsible for guiding the progression of TCR bispecific therapies from initial candidate selection through to clinical trials. This role encompasses the management of internal manufacturing operations, technology transfers, and compliance with cGMP standards at external production sites. You will work in close collaboration with various internal teams to facilitate technology transfers and ensure the prompt availability of materials for clinical research.

Key Responsibilities:
  • Direct CMC teams in the development and refinement of processes for protein biologics.
  • Offer specialized knowledge for the nomination of Development Candidates.
  • Oversee CDMO operations and guarantee timely provision of materials for clinical trials.
  • Transfer analytical methodologies to external collaborators and supervise analytical initiatives.
  • Draft technical documentation for regulatory submissions.
  • Establish objectives and production milestones for CDMO agreements.
  • Identify strategies to enhance manufacturing efficiency.
Qualifications/Experience:
  • PhD in Biochemistry, Biology, or a related discipline.
  • 15+ years of experience in the pharmaceutical or biotechnology sector with a focus on management.
  • Proven track record in technology transfer, process development, and the production of protein therapeutics.
  • Comprehensive understanding of drug development processes and research operations management.
  • Demonstrated leadership abilities and skills in cross-functional collaboration.
  • Experience with bispecific protein products is advantageous.
  • Capability to facilitate strategic discussions and manage external partnerships.

At Repertoire, we are committed to cultivating an inclusive environment that celebrates diversity and innovation. As an Equal Opportunity Employer, we prioritize equity in all facets of our workplace.

Join us in our endeavor to redefine immune therapies and significantly impact the lives of patients.