Technical Manager, Drug Product

Compass Pathways•New York, NY

3d•Hybrid

About The Position

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.

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
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

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
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

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