Overview

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.

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.

Qualifications

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.

 

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.  Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment.  Under federal law, only truthful information may be provided on the Form I-9.

Shift Information

After 3 months, you will:

• Develop a strong understanding of NorthStar's CDMO business, project lifecycle, sponsor expectations, and cGMP environment while building relationships with key internal and external stakeholders. 
• Support project planning and execution activities, including maintaining project schedules, tracking action items, preparing status updates, coordinating meetings, and managing project documentation. 
• Gain proficiency in NorthStar's project management processes and begin contributing to project risk identification, resource planning, and cross-functional coordination efforts.

After 6 months, you will: 

• Independently manage assigned CDMO projects, serving as the primary liaison between sponsors and internal teams while ensuring alignment with project objectives, timelines, and customer expectations.
• Lead project meetings, maintain project plans and dashboards, proactively identify and mitigate risks, and drive accountability for project deliverables and milestones. 
• Coordinate technology transfer and project readiness activities, provide leadership across cross-functional teams, and contribute to continuous improvement initiatives that enhance project execution and customer satisfaction.

 

 

Benefits

• Medical, dental, and vision insurance
• Healthcare Flex Spending Account (FSA) and Dependent Care FSA
• Company-paid short-term and long-term disability
• Company-paid life insurance & AD&D coverage
• Pet insurance
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• Bonus plan
• Equity Incentive Program

Working Conditions

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:

• Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors
• Noise levels range from quiet to loud, depending on the work area
• Specific vision abilities, including near vision, visual acuity, and color discrimination

Personal Protective Equipment (PPE) is required and may include:

• Respirators, gloves, safety glasses, and full protective clothing
• Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)
• Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions

As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:

• Follow strict radiation safety procedures
• Participate in dosimetry monitoring and bioassay testing as part of the company protocol
• Inform leadership of any health conditions that may affect product integrity, by cleanroom standards

Location

NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.

Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you’re drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families considering relocation.

Please note that this position is eligible for a lump sum relocation benefit!