Associate Director, MSAT
Listed on 2026-07-06
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Pharmaceutical
Regulatory Compliance Specialist, Validation Engineer
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 roleThe Associate Director, Manufacturing Science & Technology (MSAT) provides technical and people leadership for MSAT activities supporting pharmaceutical and/or radiopharmaceutical drug product manufacturing across internal manufacturing operations and external contract manufacturing organizations. This role is accountable for the design, development, transfer, and lifecycle support of robust manufacturing processes to ensure reliable, compliant product supply.
The Associate Director, MSAT serves as a principal technical expert and process owner for assigned products and manufacturing networks, leading cross‑functional teams to execute technology transfer, process validation, investigations, and continuous improvement initiatives in alignment with cGMP requirements, internal quality systems, and regulatory filings.
This position is based in New Jersey and requires a presence on‑site 4 days per week
, and is open to applicants authorized to work for any employer within the United States.
- Act as MSAT technical lead and process owner for assigned products and manufacturing networks across internal sites and external manufacturing partners.
- Lead and oversee technology development and technology transfer activities from early implementation through clinical and commercial manufacturing, including process characterization, equipment qualification, validation, and manufacturing readiness.
- Provide technical and strategic oversight to ensure manufacturing processes are designed, validated, and maintained in compliance with applicable cGMPs, internal procedures, and regulatory commitments.
- Lead and manage MSAT staff, including assignment of work, prioritization of activities, mentoring, and technical development of team members.
- Oversee and approve deviation investigations, root cause analyses, CAPAs, and change controls related to manufacturing processes, equipment, materials, or sites.
- Review, approve, and coauthor key technical documentation including technology transfer packages, validation strategies, protocols, reports, and regulatory support documents (CMC related).
- Partner with Manufacturing, Quality, Validation, Engineering, Supply Chain, and external partners to resolve complex technical issues and support uninterrupted product supply.
- Provide hands‑on technical leadership and decision‑making support during manufacturing startup, tech transfer execution, and significant process changes.
- Establish and maintain effective working relationships with CDMO leadership and site teams; serve as a senior MSAT interface for external manufacturing partners.
- Support regulatory inspections, audits, and health authority interactions as a technical subject‑matter expert, including preparation and review of responses.
- Contribute to the development, harmonization, and continuous improvement of MSAT business processes, standards, and SOPs across the manufacturing network.
- Actively promote safety rules and awareness, demonstrating good safety practices at all times and taking initiative to correct safety and environmental hazards.
- Actively demonstrate…
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