Lead Project Manager- CMO Tech Transfers

Job Description

Job Description SummaryThe Lead Project Manager will lead and support technology transfer projects supporting the growth of PET CMO & supply chain network in USCAN. This role ensures successful scale-up, validation, and commercial readiness of drug products while maintaining compliance with regulatory standards and company quality systems. The position requires strong technical understanding, cross-functional leadership, and expertise in managing complex external partnerships.

Job DescriptionRoles and ResponsibilitiesProject Leadership & Execution:Manage end-to-end tech transfer projects for PET drug product manufacturing at CMOs. Develop and maintain detailed project plans, timelines, and resource allocation strategies. Supervise early-phase activities (document management/approvals, meeting cadence) and refine processes based on initial findings or feedback. Collaborate with stakeholders to define project goals, scope, deliverables, and success metrics.

Ensure alignment with regulatory, quality, and operational requirements. Technical Coordination:Collaborate with Process Development, Quality Assurance, Regulatory Affairs, and MSAT teams to ensure robust transfer packages.

Support scale-up activities, process validation, and readiness for commercial production. Risk & Compliance Management:Identify and mitigate project risks related to technical feasibility, regulatory compliance, and commercial readiness. Ensure adherence to GMP, Part 212 compliance, and relevant SOPs throughout the transfer process.

Continuous Improvement:Drive lessons learned and best practices for future tech transfers. Support process optimization initiatives across external manufacturing network. Required QualificationsEducation: Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, or related field.

Experience:6+ years in pharmaceutical manufacturing or technical operations, with at least 3 years in project management. Proven experience managing tech transfers with CMOs for drug substance or drug product.

Skills:Strong knowledge of GMP, regulatory requirements, and validation principles. Excellent communication, negotiation, and stakeholder engagement skills. Proficiency in project management tools (MS Project, Smartsheet, etc.

)Travel: Ability and willingness to travel 10% of time with advanced notice. Core CompetenciesTechnical Expertise in Pharmaceutical ManufacturingCMO/CDMO ExperienceLeadership & InfluenceRisk ManagementRegulatory & Quality Compliance#LI-PH1#LI-REMOTEWe will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.

S. based positions only, the pay range for this position is $108,000. 00-$162,000.

00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location.

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