MSAT CDMO Manager
Lantheus · Springfield, NJ · 1 wk ago
On-siteOTHR$111k–$185k/yrFull-time
Responsibilities
- Lead multiple MSAT projects, including full technology transfer execution from initiation through commercial manufacturing.
- Lead and manage team staff, including assignment of work, prioritization of activities, mentoring, and technical development of team members.
- Serve as primary MSAT technical lead for assigned manufacturing sites and external partners.
- Oversee and approve deviation investigations, CAPAs, and change controls.
- Provide technical oversight for process validation, qualification, and lifecycle management activities.
- Review and approve technical documentation including tech transfer packages, validation strategies, and regulatory support documents.
- Provide strategic input into control strategies, process robustness, and continuous improvement initiatives.
- Lead, mentor, and develop MSAT scientists; assign work and manage priorities.
- Collaborate with Quality, Manufacturing, Validation, Supply Chain, and Regulatory Affairs to ensure aligned execution.
- Represent MSAT during regulatory inspections, audits, and governance forums.
- Actively promote safety culture and Lantheus values.
Requirements
- Bachelor’s degree with 7+ years of relevant experience; Master’s degree with 5+ years; or PhD with 3+ years of relevant experience.
- Demonstrated experience leading tech transfer and manufacturing support activities in a regulated environment.
- Prior experience managing or leading technical teams.
- Strong understanding of cGMPs and regulatory expectations.
- Willingness to work onsite and travel up to ~20% as required.
- Strong leadership, communication, and decision-making skills.
- Able to manage multiple complex technical initiatives concurrently.
- Strong organizational, communication, and problem-solving skills.
- Experience with radiopharmaceuticals is preferred.
- Understanding GMP/GLP principles.
- Knowledge of hazardous material safety and cGMP requirements.
- Strong attention to detail and documentation accuracy.
- Previous lab experience in Manufacturing and/or Quality Control at an aseptic processing facility is preferred.
- Previous experience in Quality, Compliance and/or Manufacturing of radiopharmaceutical products is preferred.
Core Values
The Ideal Candidate Will Embody Lantheus Core Values
Let people be their best
Respect one another and act as one
Learn, adapt, and win
Know someone’s health is in our hands
Own the solution and make it happen
Pay Range
The pay range for this position is between $111,000 and $185,000 annually.
Benefits
Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave.