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Let’s build the future of medicine - together.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 - are you ready to make a difference?Your Role in Our MissionAt 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.What You’ll DoLead 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 timelinesProvide technical and strategic leadership for small-molecule OSD development programsOwn drug product development strategy from pre-IND through Phase 3, ensuring phase-appropriate design, control strategy, and documentationEnsure strict adherence to global regulatory guidelines throughout the manufacturing, packaging, and testing processesServe as the technical authority for OSD formulation development and manufacturing within CMC and the primary point of contact during discussions with health authorities worldwideReview and approve controlled drug product development and manufacturing documentationLead the preparation and critical review of CMC documents for regulatory submissionWork cross-functionally with Regulatory Affairs and Quality Assurance to ensure regulatory compliance and seamless implementation of CMC standards and cGMP regulationsContribute to the development and oversight of project-level CMC budgets, emphasizing cost-effectiveness without compromising qualityWe’re Looking ForLead 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 timelinesProvide technical and strategic leadership for small-molecule OSD development programsOwn drug product development strategy from pre-IND through Phase 3, ensuring phase-appropriate design, control strategy, and documentationEnsure strict adherence to global regulatory guidelines throughout the manufacturing, packaging, and testing processesServe as the technical authority for OSD formulation development and manufacturing within CMC and the primary point of contact during discussions with health authorities worldwideReview and approve controlled drug product development and manufacturing documentationLead the preparation and critical review of CMC documents for regulatory submissionWork cross-functionally with Regulatory Affairs and Quality Assurance to ensure regulatory compliance and seamless implementation of CMC standards and cGMP regulationsContribute to the development and oversight of project-level CMC budgets, emphasizing cost-effectiveness without compromising qualityIf you’re passionate about innovation and impact, we encourage you to apply even if you don’t meet every requirement.Our Values: Curiosity | Agency | Journey | Charity | UnityBenefits: 90% Medical, Dental, Vision | 401k Match | Flexible PTO | Adoption Assistance
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