About the position
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways. We are looking for our first Technical Subject Matter Expert in Drug Product to join our team and contribute to our innovative projects and commercial production. You'll provide strategic technical input, manage manufacturing partnerships, contribute to CMC regulatory submissions, and drive product/process improvements. If you're an experienced pharmaceutical professional eager to drive innovation in drug development and ensure robust compliance, this role offers a compelling challenge.
Responsibilities
- Technical Subject Matter Expert for all aspects of Compass’ Drug Products (DP) in the US in particular, and also aspects of Compass Drug Substances (DS) where appropriate
- Manage, track, and report progress on DP projects and commercial production programs, and provide strategic and technical input to these projects/programs
- Ensure effective relationships with Compass’ Manufacturing partners (CMOs/CDMOs and key suppliers) as required, meeting business objectives and timelines
- Contribute to the writing of relevant dossier sections for CMC regulatory submissions, and ensure technical compliance with recognised regulations and standards
- Identify opportunities for product and process improvements during development and scale up
- Support the Manufacturing & Supply team in any section-related activities as required and as appropriate
- Support compliance and efficiency related projects
- Identify risks, implement mitigation & controls, monitor & report status
Requirements
- Minimum of Bachelor’s degree in science, or equivalent
- Demonstrated relevant experience within the pharmaceutical industry; must have DP experience across a variety of formulations and dosage forms
- Experience working with, or for, contract manufacturing organisations (CMOs/CDMOs)
- Experience of contributing to CMC Regulatory content
- Experience in technology transfer, process validation and process monitoring
- Technical experience supporting manufacturing within a Quality Management System
- Ability to prioritise tasks and objectives to ensure business goals are achieved
Nice-to-haves
- Excellent interpersonal communication and strong Stakeholder management skills
- Knowledge and expertise in formulation of DP and dosage forms
- Project Planning & Risk Management
- Ability to react to changing priorities
- Flexibility and ability to multi-task
Benefits
- Base salary range: $127,500—$172,500 USD
- Additional discretionary bonuses and equity
