CMC Director - Drug Product
About The Position
Join Enveda as a CMC Director – Drug Product and help us transform natural compounds into life-changing medicines. We’re a team driven by curiosity and innovation. At Enveda, every role drives impact. As CMC Director - Drug Product, you will play a key role in executing Enveda’s pharmaceutical development and manufacturing initiatives. Your expertise will guide CMC-related activities spanning oral solid dose drug product formulation development, manufacturing, and regulatory submissions. Reporting directly to the VP, CMC, your contributions will be instrumental in executing our development and manufacturing strategies and ensuring the delivery of high-quality products to patients.
Requirements
- Lead the management and oversight of formulation development, scale-up, and tech transfer for small-molecule oral solid dose (OSD) drug product manufacturing, collaborating with external CDMOs and internal development project teams to deliver clinical drug product on established timelines
- Provide technical and strategic leadership for small-molecule OSD development programs
- Own drug product development strategy from pre-IND through Phase 3, ensuring phase-appropriate design, control strategy, and documentation
- Ensure strict adherence to global regulatory guidelines throughout the manufacturing, packaging, and testing processes
- Serve as the technical authority for OSD formulation development and manufacturing within CMC and the primary point of contact during discussions with health authorities worldwide
- Review and approve controlled drug product development and manufacturing documentation
- Lead the preparation and critical review of CMC documents for regulatory submission
- Work cross-functionally with Regulatory Affairs and Quality Assurance to ensure regulatory compliance and seamless implementation of CMC standards and cGMP regulations
- Contribute to the development and oversight of project-level CMC budgets, emphasizing cost-effectiveness without compromising quality
Nice To Haves
- If you’re passionate about innovation and impact, we encourage you to apply even if you don’t meet every requirement.
Responsibilities
- Lead the management and oversight of formulation development, scale-up, and tech transfer for small-molecule oral solid dose (OSD) drug product manufacturing, collaborating with external CDMOs and internal development project teams to deliver clinical drug product on established timelines
- Provide technical and strategic leadership for small-molecule OSD development programs
- Own drug product development strategy from pre-IND through Phase 3, ensuring phase-appropriate design, control strategy, and documentation
- Ensure strict adherence to global regulatory guidelines throughout the manufacturing, packaging, and testing processes
- Serve as the technical authority for OSD formulation development and manufacturing within CMC and the primary point of contact during discussions with health authorities worldwide
- Review and approve controlled drug product development and manufacturing documentation
- Lead the preparation and critical review of CMC documents for regulatory submission
- Work cross-functionally with Regulatory Affairs and Quality Assurance to ensure regulatory compliance and seamless implementation of CMC standards and cGMP regulations
- Contribute to the development and oversight of project-level CMC budgets, emphasizing cost-effectiveness without compromising quality
Benefits
- 90% Medical, Dental, Vision
- 401k Match
- Flexible PTO
- Adoption Assistance
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
