Sr. Director of CMC (Protein) at HireMinds

HireMinds is partnering with a new biotech seeking your expertise to help in their mission to get to IND in 2025 for rare disease patients in dire need. In this role you’ll be a pivotal hire working closely with the CEO and company advisors. As the Senior Director of CMC, you will lead CMC activities in recombinant protein therapy from academic development to clinical manufacturing. You’ll be successful in leading CMC strategies, managing CDMO partnerships/technical transfer, and ensuring compliance with quality and regulatory standards. You’ll be local to Boston and enjoy working closely in a virtual office setting with the management team and help build the development organization as the company grows. Apply today if this sounds like an exciting role for your career.

1. CMC Development: Create and execute phase-appropriate CMC strategies, focusing initially on transition to Phase I clinical trials.
2. CDMO Partner Management: Select and oversee CDMO partners for process development, analytical testing, and formulation, with emphasis on downstream purification and drug product topical gel formulation.
3. Regulatory and Quality Compliance: Implement proper CMC strategies aligned with quality and regulatory requirements, preparing submissions and responding to agency feedback.
4. Team Leadership: Provide strategic leadership, collaborate with cross-functional teams, and eventually recruit and mentor a CMC team through clinical and commercial development phases.

1. Ph.D. in Biochemistry, Chemical Engineering, or related field.
2. Biotech or Pharmaceutical success with 10+ years of experience.
3. Examples of success in downstream CMC activities preferably in recombinant protein CMC, with expertise in large, sticky, or complex proteins.
4. Proven track record in managing CDMO partnerships and ensuring GMP compliance.
5. Strong problem-solving skills and ability to adapt manufacturing processes for specialized proteins.
6. Effective communicator with ability to present plans and provide clear updates to CEO and invested stakeholders on a regular basis.