Senior Radiopharmaceutical Manufacturing Specialist (3rd Shift)

Senior Radiopharmaceutical Manufacturing Specialist (3rd Shift)

Join to apply for the Senior Radiopharmaceutical Manufacturing Specialist (3rd Shift) role at NorthStar Medical Radioisotopes, LLC

Senior Radiopharmaceutical Manufacturing Specialist (3rd Shift)

3 days ago Be among the first 25 applicants

Join to apply for the Senior Radiopharmaceutical Manufacturing Specialist (3rd Shift) role at NorthStar Medical Radioisotopes, LLC

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

The Senior Radiopharmaceutical Manufacturing Specialist performs duties to support the development and manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, batch dissolution, product synthesis, dispensing of medical radioisotopes, and aliquoting of finished patient doses, while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.

Responsibilities

• Operate as Subject Matter Expert (SME) across various aspects of radiopharmaceutical manufacturing including but not limited to the manufacturing of the intermediate and finished dose production processes. This includes pre-production set-up, manufacturing processes, post-production activities, and waste stream management.
• Mentor and train new manufacturing personnel on all safety, quality, and production systems.
• Assist in the accurate and timely preparation and completion of records related to manufacturing, including Batch Records, Forms, Log Books, etc.
• Participate in internal and external compliance audits and assist with auditor interactions as needed.
• Support the business development team in interaction with current and potential sponsors.
• Plan and organize production Work Orders on the production schedule in collaboration with leadership.
• 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 processing equipment and control systems, consumables, and cleanrooms to ensure compliant manufacturing. Notify leader of equipment or operating problems and the need for additional materials, supplies, or investigations.
• 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 facility, equipment, and materials in accordance with NorthStar's respective policies and procedures.
• Engage in completion of all workflows inside QMS including deviations, OOSs, change controls, document changes (DCO), and CAPA. Work cross-functionally on employing standardized root cause analysis, investigation tools and methodologies.
• Contribute to interdepartmental projects including production scale-up, product development, continuous process improvement which includes qualification and validation activities.
• Work with Facilities and Maintenance group on preventative maintenance (PM) review and troubleshooting implementation plan, and assist in tracking scheduled system maintenance and equipment calibrations while keeping an open line of communication.
• Monitor product quality to ensure compliance with standards and specifications by identifying and verifying appropriate materials, area conditions, and process for production. Communicate any abnormalities to the leader.

Early Development

After 3 Months, You Will :

After 6 Months, You Will :

Qualifications

Associate's Degree (AS) in a STEM discipline and minimum four (4) 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 four (4) years of cGMP experience preferred. CDMO / CMO experience, chemistry experience and knowledge of aseptic processes (cleanroom environment) and equipment qualification 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.

Shift Information

Third Shift hours are Monday - Thursday 9pm - 7 : 30am (shift ends Friday morning). During this position's training period (approximately 90 days), the ability to work 1 st shift is required, with the ability to work varying shifts at least once during the training period. Primary shift placement will occur upon completion of the training program.

Benefits

Working Conditions

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include :

Personal Protective Equipment (PPE) Is Required And May Include :

As a Radiopharmaceutical Manufacturing Site , Radiation May Be Present In The Laboratory And Production Areas. Employees In This Role May Be Required To :

Location

NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.

Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you're drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families 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.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Management and Manufacturing

Industries

Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at NorthStar Medical Radioisotopes, LLC by 2x

Sign in to set job alerts for "Manufacturing Specialist" roles.

Manufacturing Technician 1 - Rockford, TN, 37853

Manufacturing Technician 1 - Rockford, TN, 37853

Manufacturing Technician 2 (weekends only) - Rockford, TN, 37853

Manufacturing Technician 1 (2nd Shift) - Rockford, TN, 37853

Manufacturing Technician 1 (2nd Shift : 4pm to 2 : 30am) - Rockford, TN, 37853

Radiopharmaceutical Manufacturing Specialist

Pharmaceutical Manufacturing Technician - 1st Shift

Pharmaceutical Manufacturing Technician - 1st Shift

Manufacturing Project Leader - Belvidere, IL Plant

Belvidere, IL $68,700.00-$103,200.00 2 weeks ago

Pharmaceutical Manufacturing Technician 3rd Shift

Pharmaceutical Manufacturing Technician 3rd Shift

Manufacturing Engineering Technology Adjunct Faculty

Manufacturing Engineer (Fabrication Focus)

Manufacturing Processing and Packaging Engineer - Belvidere, IL Plant

Belvidere, IL $68,700.00-$103,200.00 2 weeks ago

Roscoe, IL $60,000.00-$115,000.00 1 week ago

Heat Treat Operator / Production / Manufacturing

Loves Park, IL $70,000.00-$105,000.00 1 month ago

Rockford, IL $90,000.00-$115,000.00 2 days ago

Machesney Park, IL $83,000.00-$115,000.00 1 month ago

Darien, WI $70,000.00-$80,000.00 3 weeks ago

Rockford, IL $70,000.00-$80,000.00 4 days ago

Rockford, IL $70,000.00-$80,000.00 5 days ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr