COMPASS Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving 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, COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted.
Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single 25mg dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin treatment for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States.
Our vision is a world of mental wellbeing. COMPASS Pathways.
The Technical Manager will be responsible for providing expertise on new pharmaceutical drug substances and drug products through to Commercialisation, within the R&D Team.
Location: Home based in the United Kingdom or hybrid/office based in our London office.
Reports to: The Technical Director.
Roles and responsibilities
(include but are not limited to):
- Technical Subject Matter Expert for all aspects of COMPASS Drug Substances (DS) in particular, and also aspects of COMPASS Drug Products (DP) where appropriate
- To manage, track, and report progress on DS development projects and commercial production programs, and to 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
- To 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
- To support the Manufacturing & Supply team in any section-related activities as required and as appropriate, including DP
- To support compliance and efficiency related projects
- Identify risks, implement mitigation & controls and monitor & report status
- Excellent interpersonal and communication skills
- Strong Stakeholder management skills
- Demonstrated relevant experience within the pharmaceutical industry
- Life Sciences degree (BSc and above ideally)
- Experience in DS synthetic process development, and ideally technical support of pharmaceutical products
- Experience across a variety of DP formulations is also desirable
- 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
- Knowledge and expertise in organic chemistry, and synthesis of DSs
- Project Planning & Risk Management
- Ability to react to changing priorities
- Excellent interpersonal skills
- Flexibility and ability to multi-task
We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.
COMPASS Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.