Associate Director, Technical, CMC Support – PET Quality Operations

Lantheus

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

Posted 10/22/2026full-timeRemote • Massachusetts • United StatesSenior💰 $139,000 - $232,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Quality oversight for Chemistry, Manufacturing, and Controls (CMC) activities, with a strong focus on regulatory compliance, technical transfers, and product lifecycle management. Proficient in leading cross-functional teams and communicating complex Quality matters effectively to stakeholders.

Highest-signal resume keywords

Quality OversightCGMP ComplianceTechnical TransferRegulatory SubmissionsAseptic Manufacturing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsProduct Lifecycle ManagementDeviation ManagementChange ControlCAPA ManagementEnvironmental MonitoringSterility AssuranceProcess ValidationAnalytical MethodsManufacturing Controls

Soft Skills

Excellent Communication SkillsLeadership Through InfluenceCross-Functional CollaborationPresentation SkillsMentoring

Tools & Technologies

Electronic Quality Management SystemsMicrosoft Office Applications

Certifications & Qualifications

Lean CertificationSix Sigma Certification

Industry Keywords

Pharmaceutical QualityCMC Regulatory ExpectationsFDA RegulationsICH GuidelinesRadiopharmaceutical ManufacturingSterile ProductsAudit ReadinessRisk-Based MonitoringContinuous ImprovementKPI Review

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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