Associate Director, Technical, CMC Support – PET Quality Operations

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Provide strategic and operational Quality oversight for Chemistry, Manufacturing, and Controls (CMC) activities across the PET portfolio and external manufacturing network.

• Support regulatory submissions, technical transfers, site activation, product lifecycle management, supplier and CMO oversight, and ensure ongoing compliance with cGMP and regulatory requirements.

• Author, review, and approve Module 3 content, technical reports, regulatory submissions, responses, and supporting documentation.

• Oversee Quality management for commercial product lifecycle activities, including post-approval changes, stability programs, specifications, regulatory commitments, and governance forums.

• Provide QA oversight for technical transfers from development stages to commercial readiness.

• Collaborate with internal stakeholders and external CMOs to ensure alignment of technical documentation, manufacturing controls, and Quality systems with regulatory expectations and Lantheus standards.

• Monitor external manufacturing partner Quality performance through risk-based approaches, KPI and trend analysis, audit support, due diligence, and continuous improvement initiatives.

• Assist in and authorize deviations, investigations, change controls, CAPAs, qualification documentation, site procedures, and batch-related documentation.

• Assess environmental monitoring data, sterility assurance programs, aseptic process simulation results, and microbiological or process performance trends.

• Provide technical Quality support for batch record reviews, sterility reconciliations, and product disposition.

• Lead or contribute to cross-functional governance and decision-making processes regarding changes, specifications, stability, site readiness, and product supply.

• Lead and participate in internal and external audits, as well as regulatory inspection readiness activities.

• Support responses to inquiries from regulatory authorities and inspections.

• Identify technical, regulatory, and compliance risks, and communicate assessments and recommendations to stakeholders and senior leadership.

• Mentor colleagues while promoting risk-based Quality decision-making, knowledge sharing, and continuous improvement.

⛳️ Requirements

• Bachelor’s degree in chemistry, pharmaceutical sciences, engineering, life sciences, or a related scientific field.

• At least 10 years of progressive experience in pharmaceutical Quality, manufacturing, technical operations, CMC, or a related area.

• Proven experience in supporting sterile or aseptic manufacturing and associated Quality systems.

• Strong knowledge of cGMP requirements and CMC regulatory expectations relevant to pharmaceutical manufacturing.

• Experience with technical transfers, product lifecycle management, deviations, change controls, CAPAs, and audit or inspection readiness.

• Exceptional written, verbal, and presentation skills.

• Ability to clearly communicate complex technical and Quality issues to stakeholders at all levels.

• Capability to lead by influence, manage competing priorities, and collaborate effectively across internal teams and external organizations.

• Willingness to travel to company and external partner locations as necessary.

• Applicants must have authorization to work for any employer within the United States.

• Preferred: advanced degree in a scientific, engineering, pharmaceutical, or related discipline.

• Preferred: experience with positron emission tomography (PET), radiopharmaceutical manufacturing, or other short-shelf-life sterile products.

• Preferred: experience with CMC regulatory submissions, including Module 3 content and post-approval change documentation.

• Preferred: experience in overseeing CMOs, suppliers, or external manufacturing networks.

• Preferred: technical knowledge of aseptic processing, environmental monitoring, sterility assurance, analytical methods, process validation, and manufacturing facility requirements.

• Preferred: understanding of FDA, ICH, and other relevant global regulatory requirements and guidance.

• Preferred: Lean or Six Sigma certification or experience in structured continuous improvement.

• Preferred: proficiency in Microsoft Office applications and electronic Quality management systems.

🏝️ Benefits

• Discretionary performance-based cash incentive.

• Medical coverage.

• Prescription drug coverage.

• Dental coverage.

• Vision coverage.

• Life benefits.

• Disability benefits.

• Pre-tax accounts.

• 401(k) with company contribution.

• Paid vacation.

• Paid holidays.

• Sick days.

• Paid parental leave.