Technical Manager, Drug Product

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