Director of Drug Substance

Durham, NC

MindMed is a leading mental health biotech company, focusing on novel psychedelic derived medicines. With breakthrough clinical research in psychedelic medicine and treatments, utilizing novel AI digital measures, we are turning our vision to help millions of people around the world into reality.


Founded in 2019, we are continuously expanding our presence throughout North America, central Europe and Australia and are constantly searching for high impact individuals in various clinical, technological and business operations domains to strengthen our team.


As Director of Drug Substance you will be a technical leader and subject matter expert responsible for drug substance synthetic route development, control strategy, scale-up, and GMP supply from multiple CDMOs to meet program milestones. The ideal candidate will have a core expertise in small molecule synthesis and drug substance development experience from early development through commercialization.

  

Responsibilities:


  • Lead and direct drug substance synthetic route development, manufacturing control strategy, and scale-up at partner CDMOs
  • As needed, evaluate and select drug substance manufacturing partners aligned with supply chain strategy
  • Manage relationships with CDMOs and raw material suppliers to define and drive technical deliverables, ensuring timely delivery of GMP drug substance to support pharmaceutical development, clinical trials, and registration objectives
  • Effectively partner with internal stakeholders to support drug product and nonclinical development activities
  • Review and approve batch records, development protocols and reports, batch release and stability data
  • Analyze/interpret development data to support technical decision making, trend analysis, and root cause investigations
  • Identify and mitigate drug substance development, scale-up, and supply risks
  • Lead authoring of drug substance regulatory file sections
  • Contribute to intellectual property strategy and filings where drug substance subject matter expertise is needed


Requirements:


  • Bachelor of Science degree in Chemistry or relevant discipline with a minimum of 12-15 years of pharmaceutical industry experience; Advanced degree in Chemistry (MS / PhD) is preferred
  • Strong working knowledge of current Good Manufacturing Practices (cGMP)
  • Strong working knowledge of relevant regulatory requirements, pharmacopeias, and ICH guidance
  • Subject matter expert in small molecule drug substance synthesis, scale-up, control strategies, and risk management
  • Proven track record for partnering internally and externally to deliver Drug Substance development milestones on-time and right first across the phases of clinical development through commercialization
  • Ability to effectively collaborate, communicate, and influence in a cross-functional team environment
  • Experience with US and EU regulatory filings for both clinical trial and marketing applications

Subscribe to Job Alerts