CMC Director – Drug Product

Enveda

CMC Director at Enveda leading pharmaceutical development for natural compounds into life-changing medicines. Executing strategies for drug product development and manufacturing initiatives.

Posted 6/24/2026full-timeRemote • 🇺🇸 United StatesLead💰 $215,000 - $225,000 per yearWebsite

About the role

Key responsibilities & impact

Join Enveda as a CMC Director – Drug Product and help us transform natural compounds into life-changing medicines.
Play a key role in executing Enveda’s pharmaceutical development and manufacturing initiatives.
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

What you’ll need

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

Comp & perks

90% Medical, Dental, Vision
401k Match
Flexible PTO
Adoption Assistance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

formulation developmentscale-uptech transfersmall-moleculeoral solid dosedrug product manufacturingregulatory submissionscontrol strategycGMP regulationsCMC documentation

Soft Skills

leadershipcollaborationstrategic thinkingcommunicationproject managementoversightcost-effectivenessquality assurance