CMC Director – Drug Product

DirectorDirectorFull TimeRemoteLeadTeam 201-500Since 2019H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

1 day ago

Salary

$215K - $225K / year

Seniority

Lead

Postgraduate DegreeEnglish

Job Description

CMC Director – Drug Product

Enveda

• 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.

Job 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

Benefits

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

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