Associate Director/Director, Manufacturing Operations


Position Description

Modis Therapeutics is a small and growing venture-backed biotechnology startup company focused on developing therapeutics for rare/orphan diseases. We are seeking an Associate Director/Director of Manufacturing Operations to join our team.

In this position, you will be responsible for developing and implementing strategic planning activities and assessing a supply chain for pharmaceutical manufacturing in support of global distribution. You will be responsible for maintenance of all programs under a Quality Systems approach to cGMP manufacturing.

Key Responsibilities

  • Develop and implement strategic supply chain for manufacturing operations in support of clinical investigations
  • Integrate financial data from the supply chain in order to project costs and outputs for strategic planning
  • Analyze long term manufacturing requirements for drug substance and drug product capacities
  • Represent Supply Chain on CMC and Clinical Development teams to ensure adequate supply and ensure that any changes are implemented effectively
  • Responsible for assuring accurate drug accountability/reconciliation for investigational medicinal product (IMP) issued during clinical studies to clinical sites and at the end of each study
  • Coordinate with 3rd party vendors to supply depots in global clinical trials for inventory, distribution, expiry management, returns, and destruction
  • Ensure that all supplies are controlled and distributed in accordance with GMP, GCP and GDP regulations

Desired Skills & Experience

  • BS in Business Administration, Operations Management, Supply Chain Management, Engineering, Scientific or related field (MBA or MS degree preferred)
  • 5+ years of pharmaceutical or biotechnology industry supply chain and/or manufacturing experience
  • Experience working with CMOs
  • APICS, CPIM, or CPM certifications a plus
  • Experience with cGMP compliance, review and release of cGMP product for Phase 1 – Phase 3 clinical investigations
  • Understanding of packaging, technology transfer, cGMPs, ICH guidelines, as well as CMC content of regulatory submissions
  • Detail oriented with excellent prioritization, organizational, and project management skills
  • Superior problem-solving skills
  • Effective communication skills (written and verbal)