CMC Director – Drug Product

Das ist der Job

Let's build the future of medicine - together.

Darum lohnt es sich

We're a team driven by curiosity and innovation – are you ready to make a difference?

What You'll Do 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.

Our Values Curiosity Agency Journey Charity Unity Benefits 90% Medical, Dental, Vision 401k Match Flexible PTO Adoption Assistance We are an equal opportunity employer and value diversity in all its forms.

Apply now and join a team committed to shaping the future of drug discovery. #J-18808-Ljbffr Join Enveda and help us transform natural compounds into life-changing medicines. Remote | Full-Time | $215,000-$225,000 Your Role in Our Mission At Enveda, every role drives impact.

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. 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. We're Looking For Proven experience in formulation development, scale‑up, and tech transfer for small‑molecule oral solid dose (OSD) drug product manufacturing.

Demonstrated technical and strategic leadership for small‑molecule OSD development programs. Experience owning drug product development strategy from pre‑IND through Phase 3. Strong knowledge of global regulatory guidelines for manufacturing, packaging, and testing.

Ability to serve as a technical authority and primary point of contact for health authorities. Experience reviewing/approving CMC documentation and leading regulatory submissions. Ability to work cross‑functionally with Regulatory Affairs and Quality Assurance. Experience managing project‑level CMC budgets.

If you're passionate about innovation and impact, we encourage you to apply even if you don't meet every requirement.