- Define and lead phase-appropriate global CMC strategies across diverse therapeutic modalities.
- Oversee the preparation and submission of CMC documentation for IND, CTA, BLA, NDA, MAA, and IMPD filings.
- Represent the CMC function during health authority interactions.
- Provide technical guidance on scalable manufacturing and analytical strategies.
- Manage and resolve issues with external partners and CDMOs.
- Lead, develop, and mentor a team of 5–10 staff members.
- Collaborate cross-functionally with regulatory, non-clinical, clinical, and business development teams.
- Provide thought leadership for the company by speaking at conferences and presenting webinars.