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Radiopharmaceutical Manufacturing Specialist

2 months ago

Beloit Wisconsin, United States NorthStar Medical Radioisotopes Full time
About NorthStar Medical Radioisotopes

We are a leading manufacturer of radiopharmaceuticals, dedicated to advancing patient care and providing innovative solutions for the detection and treatment of cancer.

Job Summary

We are seeking a highly skilled Radiopharmaceutical Manufacturing Specialist to join our team. As a key member of our production team, you will be responsible for executing various aspects of radiopharmaceutical manufacturing, including pre-production setup, manufacturing processes, post-production activities, and waste stream management.

Key Responsibilities
  • Execute various aspects of radiopharmaceutical manufacturing, including pre-production setup, manufacturing processes, post-production activities, and waste stream management.
  • Assist in the accurate and timely preparation and completion of records manufacturing, including Batch Records, Forms, Logbooks, etc.
  • Review production Work Orders on the production schedule.
  • Author, review, and revise cGMP documentations, such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Works Instructions (WI), and Production Checklists while upholding NorthStar's QMS guidelines.
  • Perform safety checks and routine inspection of the production processing equipment and control systems, consumables, and cleanrooms to ensure compliant manufacturing.
  • Maintain accurate inventory of materials and consumables, and coordinate equipment traceability under the direction of the leader.
  • Perform and assist in maintaining the cleanliness and orderliness of the cleanroom and/or manufacturing spaces, equipment, and materials in accordance with NorthStar's respective policies and procedures.
Requirements
  • Associate's Degree (AS) in a STEM discipline and minimum two (2) years of cGMP experience; or equivalent combination of education and experience.
  • Relevant military experience will also be considered.
  • Bachelor's Degree (BS) in a STEM discipline and minimum two (2) years of cGMP experience preferred.
  • CDMO/CMO experience, chemistry experience and knowledge of aseptic processes (cleanroom environment) and equipment qualification preferred.
Work Environment

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.