Associate Director, PET CMC Quality & Technical Ops

Lantheus Medical Imaging, Inc.; Bedford (MA); Remote; USD 139,000 - 232,000; Full time

Benefits offered by this job

Health benefits

401(k) with company contribution

Paid time off and holidays

Job summary

Lantheus Medical Imaging, Inc. seeks an Associate Director, Technical & CMC Support (PET Quality Operations) to oversee CMC activities across the PET portfolio and external manufacturing network.

You will support regulatory submissions, technology transfers, site activations, lifecycle management, supplier oversight, and cGMP compliance. As a cross-functional partner to Technical Operations, Regulatory Affairs, Manufacturing, and CMOs, you will apply strong technical judgment and leadership to

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, engineering, life sciences.
• 10+ years of progressive experience in pharmaceutical Quality, manufacturing, CMC, or related function.
• Experience with sterile or aseptic manufacturing and quality systems.
• Strong knowledge of cGMP requirements and regulatory expectations.
• Experience with technical transfer, product lifecycle management, deviations, and CAPAs.
• Ability to communicate complex technical topics clearly to stakeholders.
• Travel willingness to sites as required.

Responsibilities

• Lead and support CMC Quality activities, including authoring, review, and approval of Module 3 content, regulatory submissions, responses, and supporting documentation.
• Provide Quality oversight for product lifecycle management, including post-approval changes, stability programs, specifications, regulatory commitments, and associated governance forums.
• Provide QA oversight for technical transfers from development through commercial readiness, including analytical and process transfer documentation, qualification activities, readiness assessments, and site activation.
• Partner with internal stakeholders and external contract manufacturing organizations (CMOs) to ensure technical documentation, manufacturing controls, and Quality systems remain aligned with regulatory expectations and Lantheus standards.
• Oversee Quality performance of external manufacturing partners through risk-based monitoring, review of key performance indicators and trends, audit support, due diligence, and continuous improvement activities.
• Support and approve deviations, investigations, change controls, CAPAs, qualification documentation, site procedures, and batch-related documentation, as assigned.
• Evaluate environmental monitoring data, sterility assurance programs, aseptic process simulation outcomes, and microbiological or process performance trends to identify risk and drive appropriate action.
• Provide technical Quality support for batch record review, sterility reconciliation, and product disposition activities to ensure decisions are compliant and scientifically justified.
• Lead or contribute to cross-functional governance and decision-making for changes, specifications, stability, site readiness, product supply, and other technical or compliance matters.
• Lead and participate in internal and external audits and regulatory inspection readiness activities, including preparation, execution, response development, and follow-up commitments.
• Support responses to regulatory authority questions and inspections and help ensure inspection readiness across supported products, sites, and activities.
• Identify emerging technical, regulatory, and compliance risks; communicate clear assessments and recommendations to stakeholders and senior leadership.
• Mentor colleagues and promote consistent, risk-based Quality decision-making, knowledge sharing, and continuous improvement across the organization.

Skills

CMC Quality

Regulatory submissions

Quality leadership

Cross-functional collaboration

Analytical problem solving

Education

Bachelor’s degree in chemistry, pharmaceutical sciences, engineering, life sciences

Advanced degree (preferred)

Tools

MS Office

eQMS

Regulatory databases

Job description

Lantheus Medical Imaging, Inc. seeks an Associate Director, Technical & CMC Support (PET Quality Operations) to oversee CMC activities across the PET portfolio and external manufacturing network.

You will support regulatory submissions, technology transfers, site activations, lifecycle management, supplier oversight, and cGMP compliance. As a cross-functional partner to Technical Operations, Regulatory Affairs, Manufacturing, and CMOs, you will apply strong technical judgment and leadership to