Remote Associate Director, PET Quality & CMC Support

Lantheus Medical Imaging Inc; Massachusetts; Hybrid; USD 139,000 - 232,000; Full time

Benefits offered by this job

Health benefits

401(k) with company contribution

Generous time off

Job summary

Lantheus Medical Imaging Inc. is seeking an Associate Director, Technical & CMC Support (PET Quality Operations) to provide strategic Quality oversight for CMC activities across the PET portfolio and external manufacturing network.

You will support regulatory submissions, technical transfers, site activation, and lifecycle management. The role requires remote work eligibility within the United States with travel to company and partner sites.

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, engineering, life sciences, or a related scientific discipline.
• 10+ years of progressive experience in pharmaceutical Quality, manufacturing, technical operations, CMC, or related function.
• Experience supporting sterile or aseptic manufacturing and related Quality systems.
• Strong working knowledge of cGMP requirements and CMC regulatory expectations.
• Experience with technical transfer, product lifecycle management, deviations, change controls, CAPAs, and audits/inspections.
• Excellent written, verbal, and presentation skills; ability to communicate complex technical and Quality matters clearly.
• Ability to lead through influence and manage competing priorities across functions and partners.

Responsibilities

• Lead and oversee CMC Quality activities including Module 3 content, reports, regulatory submissions, and supporting documents.
• Provide QA oversight for product lifecycle management, including post-approval changes and stability programs.
• Oversee QA for technical transfers from development to commercial readiness; manage readiness assessments and site activation.
• Coordinate with CMOs to maintain alignment with regulatory expectations and Lantheus standards.
• Monitor external manufacturing partners' quality performance via KPIs, audits, and continuous improvement actions.
• Approve deviations, investigations, change controls, CAPAs, and related documentation as assigned.
• Evaluate environmental monitoring and sterility data to identify risks and drive actions.
• Support batch record review, sterility reconciliation, and product disposition with scientific justification.
• Lead governance for changes, specifications, stability, site readiness, and supply decisions.
• Lead internal and external audits and inspection readiness activities; respond to regulatory inquiries.

Skills

Leadership through influence

Cross-functional collaboration

Regulatory submissions

Quality oversight

Communication

Education

Bachelor’s degree in chemistry or related

Tools

Microsoft Office

eQMS / electronic quality systems

Job description

Lantheus Medical Imaging Inc. is seeking an Associate Director, Technical & CMC Support (PET Quality Operations) to provide strategic Quality oversight for CMC activities across the PET portfolio and external manufacturing network.

You will support regulatory submissions, technical transfers, site activation, and lifecycle management. The role requires remote work eligibility within the United States with travel to company and partner sites.