NorthStar Medical Radioisotopes, LLC

Senior Manager, CDMO/CMO

Job Locations US-WI-Beloit
ID
2024-1730
Category
Operations
Position Type
Regular Full-Time

Overview

Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team.

 

NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer, and customized radiopharmaceutical development services.

 

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, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

Position

The Senior Manager, CDMO/CMO role will have the unique opportunity to participate in the launch of a new business within NorthStar. The Senior Manager, CDMO/CMO, will work closely with other departments to complete, staff and operationalize the CDMO facility. This role will lead the CDMO Operations team and collaborate with other support functions to meet customer demands while maintaining the facility in the highest level of Quality and Safety compliance. The Senior Manager, CDMO/CMO will work with NorthStar Senior Management to achieve the strategy, vision, and objectives for the CDMO/CMO business. In addition to the primary CDMO/CMO responsibilities, this position may be requested to lead additional projects/initiatives as directed by senior management based on skill and experience.

Responsibilities

  • Work with the NorthStar team and other SMEs to make the CDMO facility ready for operation.
  • Provide leadership and project management for the production of a range of antibody-based therapeutic radiopharmaceuticals. Manage timelines deliverables, budget, and resources necessary to support the operations of the CDMO business.
  • Manage the manufacturing of radiolabeled molecules per applicable quality and regulatory standards.
  • Manage a team of people to perform day-to-day operations, develop production schedules and meet customer requirements.
  • Assist in defining, documenting and implementing operational processes with a customer focused approach.
  • Respond to non-conformities and other issues raised by internal/external customers, in a timely manner following NorthStar’s procedures and processes.
  • Review, analyze, and interpret development and manufacturing issues; work cross-functionally with internal and external stakeholders to develop resolution strategies.
  • Collaborate with the leadership of the CDMO Development and CDMO Commercial teams to ensure customer satisfaction and to expand the CDMO business.
  • Develop a proactive team-based approach to ongoing industry trends in therapeutic radioisotope CDMO landscape and present analysis to NorthStar Management teams.
  • Work with the NorthStar management team to create and implement product/brand strategies and associated tactics specific for the therapeutic radioisotopes CDMO business to achieve or exceed annual and long-range (3 to 5 years) revenue and profit targets.

Qualifications

BA/BS in Engineering or related Life Sciences field and a minimum of seven (7) years progressive, related experience, or equivalent combination of education and experience, with a minimum of three (3) years of leadership experience.  Demonstrated record of establishing and executing effective manufacturing strategy across global markets and multiple products.  Experience in project and budget execution, negotiating service agreements and managing external vendors, as well as an understanding of regulatory requirements related to radiopharmaceutical development, manufacturing in both US and OSU markets.  Experience in radiopharmaceutical company is preferred and an advanced degree is a plus.

 

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.

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.

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