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Director, Internal Manufacturing
Job in
Springfield, Union County, New Jersey, 07081, USA
Listed on 2026-06-07
Listing for:
Lantheus Holdings, Inc.
Full Time
position Listed on 2026-06-07
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
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.
Summary of role
As a key member of the Evergreen Manufacturing site senior leadership team, the Director, Internal Manufacturing provides technical and operational leadership across radiopharmaceutical manufacturing (e.g., RLT, PET and isotope products). This role is accountable for robust, compliant, and reliable manufacturing performance through the end-to-end product lifecycle-from process design and tech transfer through routine commercial execution and continuous improvement-while ensuring operations remain in full cGMP compliance and aligned with all applicable Federal, State, and local laws and regulations.
This Technical Leader partners closely with Quality, Engineering, Employee Health and Safety, Radiation Safety, Supply Chain, Chemistry Manufacturing and Controls/Regulatory, and external partners to deliver safe, on-time product and to advance technical capability, capacity, and operational excellence.
This position is based in New Jersey and requires a presence on-site 5 days per week, and open to applicants authorized to work for any employer within the United States.
Responsibilities
* Provide day-to-day technical leadership for Evergreen Manufacturing Operations and the MSAT team, ensuring safety, quality, service, cost, and people performance is measured, analyzed, and improved to meet business objectives. Scope includes production teams, facilities, RSO/EHS, and manufacturing process support. Establish and govern key metrics (e.g., right-first-time, batch release cycle time, deviation rate, OEE, EM performance) and use leading indicators to anticipate and mitigate risks to product supply.
* Contribute to site and network strategy for radiopharmaceutical manufacturing, including capacity planning, capital investment, facility/utilities strategy, sourcing, make/buy decisions, partnering models, and development of technical capabilities required for just-in-time manufacturing and cold-chain distribution.
* Develop and maintain deep technical expertise in radiopharmaceutical manufacturing (RLT, PET and isotope products), including radioactive material handling and controls, radiochemistry/radio synthesis, automated synthesis platforms, aseptic processing, sterile filtration/fill-finish interfaces (as applicable), in-process controls, and analytical/quality attributes. Ensure technical knowledge is translated into robust procedures, training, and standardized ways of working.
* Lead and/or sponsor capital projects and technical upgrades from concept through execution, including user requirements, design review, risk assessments, vendor management, commissioning/qualification/validation (CQV), and readiness for GMP use. Ensure changes are implemented through compliant change control and support rapid issue resolution during start-up.
* Serve as a key manufacturing technical representative during regulatory interactions and inspections (e.g., FDA, EMA and other agencies). Ensure sustained inspection readiness, effective responses to information requests, and timely completion of CAPAs. Partner with CMC/Regulatory on dossier content (as applicable) related to manufacturing, process validation, control strategies, and comparability/changes.
* Demonstrate visible, hands-on…
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