CDMO Project Manager

Overview

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.

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
• Continuously seek opportunities to optimize project execution, improve efficiency, and enhance customer satisfaction.

Qualifications

Bachelor’s degree in Engineering or similar related degree and six to nine years of experience as a Project Manager in a regulated engineering, manufacturing, or related industry, with at least 5 years of experience in a technical role; or equivalent combination of education and experience. Direct product development or pharmaceutical production system development experience highly preferred.

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.

Working Conditions

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.

The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures.  The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions.  Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols.  This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment.  In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders. 

The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.

Location

NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.

Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.

NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.