Associate Director, Technical & CMC ; PET Quality Operations

Job Category : Quality Assurance

Requisition Number : ADTEC
003950

Showing 1 location

Bedford - Remote

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years.

Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world.

At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress.

Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands.

Summary of Role

We are seeking an Associate Director, Technical & CMC Support (PET Quality Operations) to provide strategic and operational Quality oversight for Chemistry, Manufacturing, and Controls (CMC) activities across the PET portfolio and external manufacturing network. This role supports regulatory submissions, technical transfers and site activation, product lifecycle management, supplier and CMO oversight, and continued compliance with applicable current Good Manufacturing Practice (cGMP) and regulatory requirements.

The Associate Director, Technical & CMC Support will serve as a key cross-functional partner to Technical Operations, Regulatory Affairs, Manufacturing, Supply Chain, and external manufacturing partners. The successful candidate will apply strong technical judgment and Quality leadership to resolve complex issues, maintain product and process integrity, support reliable supply, and advance continuous improvement.

This is a remote position open to applicants authorized to work for any employer within the United States. Travel to Lantheus and external partner sites is required, as business needs dictate.

Responsibilities

• Lead and support CMC Quality activities, including authoring, review, and approval of Module 3 content, technical reports, regulatory submissions, responses, and supporting documentation.
• Provide Quality oversight for commercial 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, corrective and preventive actions (CAPAs), qualification documentation, site procedures, and batch-related documentation, as assigned.
• Evaluate environmental monitoring data, sterility assurance programs, aseptic process simulation…