CDMO Project Manager

NorthStar Medical Radioisotopes • Beloit, WI

10d

About The Position

This position will shepherd Contract Development and Manufacturing Organization (CDMO) projects through their life cycle at NorthStar, including initial kickoff, technology transfer, validation, and drug product manufacturing, both clinical and commercial. The CDMO Project Manager is responsible for providing internal and external leadership for CDMO projects. This role will serve as the main contact for driving the tactical execution of CDMO projects upon contract approvals. This role may also provide support to the Commercial organization in the outreach and courting of new sponsors.

Requirements

• Bachelor’s degree in technical discipline and minimum six (6) years of project management experience in the life science industry, inclusive of a minimum of two (2) years of cGMP experience, and at least five (5) years of experience in a technical role in life science operations including some technology transfer experience; or equivalent combination of education and experience.
• Knowledge of cGMP working environment would be beneficial.
• PMP Certification highly desirable.

Responsibilities

• Lead the end-to-end project management of CDMO projects from kickoff through technology transfer, validation, and manufacturing (clinical and commercial phases).
• Act as the main liaison between sponsors, internal teams, and external partners to manage expectations, provide updates, and escalate issues when necessary.
• Develop, manage, and track comprehensive project plans, charters, schedules, and deliverables, ensuring alignment with business goals and sponsor expectations.
• Support Operations management, Business Development and Finance to achieve project revenue targets and summarize project-level financial performance.
• Collaborate with facility management and other functions to determine resource requirements for each project, including personnel, equipment, and materials.
• Organize project dashboards and project performance reports for management, communicating delays/problems and providing mitigation plans and recommendations, as necessary.
• Develop a high-level understanding of all aspects of the project to serve as a liaison for questions and comments regarding project status.
• Work closely with internal and external stakeholders to clearly define project goals, both short-term and long-term, for broader dissemination.
• Continuously seek opportunities to optimize project execution, improve efficiency, and enhance customer satisfaction.

Benefits

• NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, paid parental leave and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees