MSAT CDMO Manager
About The Position
The MSAT CDMO Manager provides technical and people leadership for MSAT activities supporting pharmaceutical and/or radiopharmaceutical drug product manufacturing across internal and external manufacturing networks. This role is accountable for execution of multiple technology transfer and manufacturing support projects while ensuring alignment with cGMP requirements and business objectives. The MSAT CDMO Manager leads MSAT staff, interfaces with senior stakeholders, and ensures delivery of technically sound and compliant manufacturing solutions. 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.
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.
- Ability to manage multiple complex technical initiatives concurrently.
- Strong organizational, communication, and problem-solving skills.
- Understanding GMP/GLP principles.
- Knowledge of hazardous material safety and cGMP requirements.
- Strong attention to detail and documentation accuracy
Nice To Haves
- Experience with radiopharmaceuticals is preferred.
- 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.
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.
Benefits
- Comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
- Life and disability benefits.
- Pre-tax accounts.
- 401(k) with company contribution.
- Generous time off package including paid vacation, holidays, sick days, and paid parental leave.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
