Technical Manager, Drug Product

Company introduction:

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.

Job Overview:   

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. 

Location: Hybrid in our New York City office or Remote in the United States.   

Reports to: Technical Director, Manufacturing and Supply.  

Roles and responsibilities  
(Include but are not limited to):  

• 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 

• To manage, track, and report progress on DP 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 

• To support compliance and efficiency related projects 

• Identify risks, implement mitigation & controls, monitor & report status 

Candidate Profile: 

• Education level 
  • Minimum of Bachelor’s degree in science, or equivalent
    
    
• Experience 
  • 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 
    
    
• Specific skills 
  • 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 & Compensation:

For an overview of our benefits package and compensation information, please visit  "Working at Compass".  

Equal opportunities: 

UK applicants

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.

US applicants

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.

Sponsorship:

Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.

Data Privacy:

All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.