Senior Specialist, PET QA Ops

Lantheus • Bedford, MA

7h • Hybrid

About The Position

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. 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 a presence on-site of two or three days per week, and is open to applicants authorized to work for any employer within the United States.

Requirements

• Bachelor’s degree or equivalent is required in a related medical, science or engineering discipline.
• Minimum of 4-7 years of quality assurance / supplier quality engineering experience in a pharmaceutical environment.
• Excellent written, verbal and presentation skills. Must be able to interact effectively with all levels of management.
• Must have a good understanding of cGMP requirements by FDA, EMA, and ICH.
• Proficient with Microsoft office applications.
• Strong attention to detail.
• Ability To adapt to multiple and shifting priorities.

Nice To Haves

• Experienced in Positron emission tomography (PET) manufacturing and regulations.
• Experienced in Aseptic manufacturing, including strong technical understanding of aseptic manufacturing processes, equipment and facilities requirements.
• Black belt or green belt six sigma / LEAN.
• 10% travel if required.

Responsibilities

• Collaborates closely with QA team and cross‑functional partners, including senior leadership, to ensure Lantheus maintains high‑quality SOPs and processes across the Quality Management System (QMS).
• Plans, organizes, and supports all QA Operations activities related to material release, PET Manufacturing Facility (PMF) deviations and investigations, change management, metrics, batch record review, and Annual Product Report reconciliation. Collaborates with QA team on quality oversight of PMF operations.
• Develops, maintains, and routinely reviews Supplier Quality procedures to ensure compliance with customer requirements and applicable local, state, federal, and international regulations.
• Oversees supplier performance by maintaining key metrics, analyzing trends, and communicating meaningful insights to senior Lantheus leadership and external suppliers as appropriate.
• Oversees investigations of supplier and manufacturing related issues and ensures timely completion of follow‑up actions and corrective actions to reduce or eliminate defects.
• Identifies, recommends, and implements enhancements to the Supplier Quality Program driven by new regulations, agency guidance, industry standards, emerging technologies, and internal business needs.

Benefits

• comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage
• life and disability benefits
• pre-tax accounts
• a 401(k) with company contribution
• a variety of other benefits
• generous time off package including paid vacation, holidays, sick days, and paid parental leave
• discretionary performance-based cash incentive
• discretionary annual equity award

What This Job Offers

• Job Type: Full-time
• Career Level: Senior