Technical Manager, Drug Product at Compass Pathways

New York, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Jun, 26

Salary

172500.0

Posted On

16 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Subject Matter Expert, Drug Product, Drug Substance, Manufacturing Partnerships, CMC Regulatory Submissions, Process Improvements, CMOs/CDMOs, Technology Transfer, Process Validation, Process Monitoring, Quality Management System, Interpersonal Communication, Stakeholder Management, Formulation, Project Planning, Risk Management

Industry

Mental Health Care

Description

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, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - 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 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】: $127,500—$172,500 USD Benefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. 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.

Responsibilities

The role involves serving as the primary Technical Subject Matter Expert for Drug Products in the US, managing manufacturing partnerships, and contributing strategic technical input to projects and commercial production programs. Responsibilities also include authoring relevant sections for CMC regulatory submissions and identifying opportunities for product and process improvements during development and scale-up.