Job description
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.
Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.
As Associate Director, Drug Substance Development you will be a technical leader and subject matter expert responsible for the synthetic route development, control strategy, scale-up, and 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
- 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
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
The starting base pay range for this position is $157,262.00 - $185,491.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
- 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!
