Senior Specialist, PET QA Ops

About Lantheus

Lantheus (NASDAQ: LNTH) is a 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, it has been providing radiopharmaceutical solutions for nearly 70 years.

We are seeking a team member to support and continuously enhance Lantheus's PET QA Operations program, ensuring that systems, processes, and procedures are compliant, harmonized, and optimized to meet regulatory expectations and business objectives. This position is based in MA and requires on‑site presence two or three days per week, and is open to applicants authorized to work in the United States.

• Collaborate closely with the QA team and cross‑functional partners, including senior leadership, to ensure Lantheus maintains high‑quality SOPs and processes across the Quality Management System.
• Plan, organize, and support all QA Operations activities related to material release, PET Manufacturing Facility deviations and investigations, change management, metrics, batch record review, and Annual Product Report reconciliation. Collaborate with QA on quality oversight of PMF operations.
• Develop, maintain, and routinely review Supplier Quality procedures to ensure compliance with customer requirements and applicable local, state, federal, and international regulations.
• Oversee supplier performance by maintaining key metrics, analyzing trends, and communicating meaningful insights to senior leadership and external suppliers.
• Oversee investigations of supplier and manufacturing‑related issues and ensure timely completion of follow‑up actions and corrective actions to reduce or eliminate defects.
• Identify, recommend, and implement enhancements to the Supplier Quality Program driven by new regulations, agency guidance, industry standards, emerging technologies, and internal business needs.

• Bachelor's degree or equivalent in a related medical, science or engineering discipline.
• 4–7 years of quality assurance / supplier quality engineering experience in a pharmaceutical environment.
• Excellent written, verbal and presentation skills; ability to interact effectively with all levels of management.
• Good understanding of cGMP requirements by FDA, EMA and ICH.
• Proficiency with Microsoft Office applications.
• Strong attention to detail.
• Ability to adapt to multiple and shifting priorities.

• Experience in positron emission tomography (PET) manufacturing and regulations.
• Experience in aseptic manufacturing, including strong technical understanding of aseptic processes, equipment and facilities requirements.
• Black belt or green belt Six Sigma / LEAN.
• 10 % travel if required.

The pay range for this position is between $111,000 and $185,000 annually. Actual base pay offered may vary depending on factors such as job‑related knowledge, skills and experience. Employees are eligible for a discretionary performance‑based cash incentive and, depending on the level of the role, may be eligible for a discretionary annual equity award. Benefits include a comprehensive health benefits package (medical, prescription drug, dental, vision coverage), life and disability benefits, pre‑tax accounts, a 401(k) with company contribution, and generous time‑off packages (paid vacation, holidays, sick days, paid parental leave).

Applications for this position will be accepted until May 20, 2026.

Lantheus is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, creed, religion, national origin, ancestry, citizenship status, age, sex, gender identity, sexual orientation, marital status, military service, veteran status, disability, protected medical condition, genetic information, or any characteristic protected under applicable laws.

Any applicant requiring an accommodation in connection with the hiring process or to perform essential functions should request an accommodation through the Talent Acquisition team at t.

Lantheus is an E‑Verify Employer.