CDMO Product Development Technician II/Senior

4 days ago

Beloit, United States NorthStar Medical Radioisotopes LLC 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 CDMO Product Development Technician II will provide support in NorthStars radiologic science laboratories within the CDMO Product Development Department. Responsibilities include the ability to independently perform laboratory controls, maintenance and calibration of equipment, manifestation and disposal of radioactive material, preparation of laboratory solutions, assistance with product development/production, and general laboratory maintenance. This role will specialize in development, verification, and validation of current and/or new and existing radiopharmaceutical products/medical devices.

The Senior CDMO Product Development Technician will have additional responsibilities, including leading laboratory process improvements, conducting training for others entering the radiation space, and providing direction and leadership to other technicians.

Responsibilities:
  • Perform routine and non-routine experiments and/or analyses following NorthStar procedures and guidelines. Ensure data is collected and documented according to good documentation practices.
  • Independently perform tasks as needed to support product development. This may include solution preparation, equipment checks, and documentation preparation.
  • Maintain and manage specific laboratory controls including equipment calibration, radiologic assays, pharmaceutical compounding, solution preparation, inventory control, chromatography reagent preparation, and quality control testing.
  • Understand and execute the cradle-to-grave processes specific to all radioactive substances that are used in the laboratory including, but not limited, to DOT check in/check out process, waste management, and documentation/filing.
  • Collaborate and author documents related to qualification of equipment, consumables, and processes as assigned.
  • Maintain low-level radioactive waste inventory management including: storage, manifestation, and disposal in accordance with regulatory requirements.
  • Maintain supplies and manage inventory within the laboratory space.
  • Train other team members as appropriate.

The Senior CDMO Product Development Technician will have additional responsibilities, including:

  • Lead, manage, and/or perform laboratory controls involved with equipment calibration, radiologic assays, pharmaceutical compounding, solution preparation, inventory control, chromatography reagent preparation, and quality control testing.
  • Train other individuals for laboratory access and use of instruments.
  • Identify risks, issues, and opportunities for process improvements in the radiation laboratory.
  • Collaborate and author documents related to internal methods, procedures, SOPs, and reports. Intimate knowledge with document control procedures is expected.
  • Independently perform and manage tasks as needed to support product development. This may include solution preparation, equipment checks, and documentation preparation.


Qualifications:

Knowledge of ALARA principles required. Previous experience in a nuclear pharmacy, nuclear medicine department, laboratory setting, or cGMP environment preferred.

CDMO Product Development Technician II

Associates degree in a related science discipline or related medical field or completion of an accredited Nuclear Medicine Technology educational program required and minimum two (2) years of experience handling radioactive materials and operating radiation detection equipment; or equivalent combination of education and experience.

Senior CDMO Product Development Technician

Associates degree in a related science discipline or related medical field or completion of an accredited Nuclear Medicine Technology educational program required and minimum four (4) years of experience handling radioactive materials and operating radiation detection equipment; or equivalent combination of education and experience. Previous experience with CDMO 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.

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.

PLEASE NOTE: Even though the primary location for this position is Beloit, initial work will take place in our Madison (Femrite) facility until construction is complete and the operations are transitioned to Beloit.

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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