Associate Director, Technical, CMC Support – PET Quality Operations

Job not on LinkedIn

🔥 1 minute ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $139k - $232k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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Lantheus

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1956

💊 Pharmaceuticals

🏥 Healthcare

🤖 Artificial Intelligence

Pharmaceuticals • Healthcare • Artificial Intelligence

Lantheus is a pharmaceutical manufacturing company with over 65 years of experience dedicated to enhancing patient outcomes through innovative solutions in diagnostics, radiotherapeutics, and artificial intelligence. With a focus on precision diagnostics and targeted therapeutics, Lantheus enables clinicians to effectively find, fight, and follow diseases. The company is headquartered in Massachusetts and has international offices in Canada and Sweden.

📋 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 and site activation, product lifecycle management, supplier and CMO oversight, and continued compliance with cGMP and regulatory requirements • Author, review, and approve 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 governance forums • Provide QA oversight for technical transfers from development through commercial readiness • Partner with internal stakeholders and external CMOs to align technical documentation, manufacturing controls, and Quality systems with regulatory expectations and Lantheus standards • Oversee external manufacturing partner Quality performance through risk-based monitoring, KPI and trend review, audit support, due diligence, and continuous improvement • Support and approve deviations, investigations, change controls, CAPAs, qualification documentation, site procedures, and batch-related documentation • Evaluate environmental monitoring data, sterility assurance programs, aseptic process simulation outcomes, and microbiological or process performance trends • Provide technical Quality support for batch record review, sterility reconciliation, and product disposition • Lead or contribute to cross-functional governance and decision-making for changes, specifications, stability, site readiness, and product supply • Lead and participate in internal and external audits and regulatory inspection readiness activities • Support responses to regulatory authority questions and inspections • Identify technical, regulatory, and compliance risks and communicate assessments and recommendations to stakeholders and senior leadership • Mentor colleagues and promote 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 discipline • Minimum of 10 years of progressive experience in pharmaceutical Quality, manufacturing, technical operations, CMC, or a related function • Demonstrated experience supporting sterile or aseptic manufacturing and associated Quality systems • Strong working knowledge of cGMP requirements and CMC regulatory expectations applicable to pharmaceutical manufacturing • Experience with technical transfer, product lifecycle management, deviations, change controls, CAPAs, and inspection or audit readiness • Excellent written, verbal, and presentation skills • Ability to communicate complex technical and Quality matters clearly to stakeholders at all levels • Ability to lead through influence, manage competing priorities, and work effectively across internal functions and external organizations • Ability and willingness to travel to company and external partner locations, as required • Applicants must be authorized 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 overseeing CMOs, suppliers, or external manufacturing networks • Preferred: technical understanding of aseptic processing, environmental monitoring, sterility assurance, analytical methods, process validation, and manufacturing facility requirements • Preferred: knowledge of FDA, ICH, and other relevant global regulatory requirements and guidance • Preferred: Lean or Six Sigma certification or structured continuous improvement experience • Preferred: proficiency with 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