CDMO Project Manager

NorthStar Medical Radioisotopes•Beloit, WI

9d•Onsite

About The Position

Accelerate your career with NorthStar! NorthStar Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner. We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services. At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities. Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. 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. 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.

Nice To Haves

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.