Responsibilities:
- Build and manage a high-performing team to evaluate novel drug substances, drug products, devices, and platforms; partner with technical SMEs.
- Lead CMC due diligence: technical assessments, risk mitigation, and integration of CMC strategy with clinical development plans for licensing/acquisitions.
- Act as the primary CMC representative in cross-functional evaluations (R&D, Regulatory Affairs, Operations, Quality, Finance, Commercial) to integrate CMC perspectives into business strategy.
- Prepare and present technical recommendations, risk analyses, and findings to senior management and governance forums.
- Ensure seamless transition and knowledge transfer of externally sourced assets into internal development pipelines; coordinate with project management and technical teams.
- Support post-deal integration and development/resource planning to ensure clinical continuity.
- Monitor industry/regulatory developments in CMC, manufacturing, and compliance and adapt strategies.
- Manage multiple concurrent CMC diligence projects across asset types and therapeutic areas.
- Build and maintain best-in-class licensing/acquisition processes and recommend early dismissal of poor-fit ideas.
Qualifications:
- Advanced degree (PhD or MS preferred) in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related.
- 12+ years of CMC experience in pharma/biotech with due diligence and external innovation exposure.
- Proven technical team leadership and cross-functional project management.
- Deep knowledge of drug development, manufacturing, and regulatory requirements for small molecules, biologics, peptides, and combination products.
- Strong analytical, strategic problem-solving, communication, and stakeholder management.
- Experience influencing senior executives and governance bodies.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k); eligible for short-term incentive programs.