Associate Director, Drug Substance Development

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as an Associate Director, Drug Substance Development. You will lead drug substance development, manage CDMO relationships, and ensure timely drug substance delivery. Responsibilities include synthetic route development, control strategy, scale-up, and risk management. You will review and approve batch records and contribute to regulatory filings. The ideal candidate possesses expertise in small molecule synthesis and drug substance development, along with strong cGMP and regulatory knowledge. This role requires a PhD or MS in organic chemistry with significant pharmaceutical industry experience. MindMed offers competitive benefits, including 100% paid health benefits, a 401(k) program, flexible time off, and generous parental leave.

Requirements

• PhD or MS degree in organic chemistry or related discipline with a minimum of 6 years or 10 years, respectively, of pharmaceutical industry experience with demonstrated increasing responsibilities
• Strong working knowledge of current Good Manufacturing Practices (cGMPs) and Quality Systems
• 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 time
• Ability to effectively collaborate, communicate, and influence in a cross-functional team environment
• Ability to work in a remote/hybrid environment
• Ability to travel domestically and internationally as needed

Responsibilities

• Lead and direct drug substance synthetic route development, manufacturing control strategy, and scale-up at partner CDMOs
• Manage relationships with CDMOs to define and drive technical deliverables and ensure timely drug substance delivery to support pharmaceutical development and clinical trials
• Review and approve batch records, protocols, reports, and batch release and stability data
• Analyze/interpret data to support technical decision making, trend analysis, and root cause investigations
• Identify, mitigate, and document drug substance development, scale-up, and supply risks
• Effectively manage change controls, deviations, and CAPAs to expected quality standards
• Contribute to authoring of drug substance regulatory file sections

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!