Analytical Instrumentation Scientist

Overview

Join the best radiopharmaceutical company in the world!

If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. 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.

At the forefront of NorthStar’s technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission-advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package.

Position

The Analytical Instrumentation Scientist is responsible for coordinating the lifecycle management of analytical equipment across all laboratories. This role schedules and supports equipment installation, qualification, calibration, and preventive maintenance activities; ensures required documentation is completed accurately; and obtains the appropriate cross-functional approvals. The Analytical Instrumentation Scientist maintains complete and current equipment records, confirms that approved pre-execution protocols are in place before work begins, and coordinates completion and release of post-execution reports through the Quality Management System (QMS). This role serves as a central point of coordination among laboratory personnel, equipment vendors, and other stakeholders to support compliant equipment readiness and reliable laboratory operations.

Responsibilities

• Lead the technical oversight of analytical equipment lifecycle activities, including installation, qualification, calibration, preventive maintenance, repair, relocation, retirement, and associated equipment training activities to ensure compliance and operational effectiveness.
• Assess equipment lifecycle priorities and develop risk-based plans and schedules in coordination with laboratory personnel, Facilities, Engineering, Information Technology, Quality, vendors, and other stakeholders to support equipment readiness and regulatory compliance.
• Evaluate equipment performance, qualification status, and lifecycle risks and recommend actions regarding equipment readiness, remediation, and continued suitability for intended use.
• Author and revise equipment-related documentation and training materials, including qualification protocols, reports, risk assessments, procedures, work instructions, and associated controlled records.
• Apply scientific and technical expertise to determine qualification strategies, acceptance criteria, and equipment lifecycle requirements, ensuring approved protocols, work plans, permits, and supporting documentation are complete before activities are performed.
• Maintain complete, accurate, and current equipment records, including asset information, ownership, location, qualification status, calibration history, maintenance history, and related quality documentation.
• Coordinate the review, approval, execution, and archival of equipment lifecycle documentation through the Quality Management System (QMS), obtaining required cross-functional approvals as applicable.
• Ensure equipment qualification, calibration, and preventive maintenance activities are completed within established requirements and support deviations, investigations, CAPAs, change controls, audits, inspections, and periodic reviews associated with laboratory equipment.

Ability and willingness to travel domestically to vendor or company sites, as needed, up to 20% of the time.

Early Development

After 3 months, you will:

• Complete required laboratory, Quality, safety, radiation safety, and equipment-related training.
• Develop a working knowledge of analytical equipment lifecycle processes and supporting documentation.
• Become proficient in equipment records, scheduling tools, and Quality systems used to support laboratory operations.
• Coordinate routine equipment activities and maintain equipment records with guidance.

After 6 months, you will:

• Independently coordinate routine equipment lifecycle activities, documentation, and stakeholder communications.
• Maintain accurate equipment records and proactively monitor qualification, calibration, and maintenance schedules.
• Ensure required approvals and documentation are in place before equipment activities are performed.
• Support equipment-related deviations, change controls, audits, and inspections as assigned.

Qualifications

MINIMUM EDUCATION/EXPERIENCE

• Bachelor’s degree in Chemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline and three (3) years of experience in a regulated laboratory, manufacturing, engineering, or equipment coordination role; or an equivalent combination of education and experience. Experience coordinating analytical equipment installation, qualification, calibration, or preventive maintenance activities is required.

PREFERRED EDUCATION/EXPERIENCE

• Experience working in a cGMP or GLP environment is preferred. Familiarity with equipment lifecycle documentation, qualification protocols and reports, change control, deviations, computerized maintenance or asset management systems, and electronic Quality Management Systems is desired. Experience in radiopharmaceutical, pharmaceutical, biotechnology, or medical device operations is preferred.

PREFERRED CERTIFICATIONS

• Certifications related to quality systems, equipment calibration, laboratory operations, or project coordination are preferred but not required.

Benefits

• Medical, dental, and vision insurance
• Healthcare Flex Spending Account (FSA) and Dependent Care FSA
• Company-paid short-term and long-term disability
• Company-paid life insurance & AD&D coverage
• Pet insurance
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• Bonus plan
• Equity Incentive Program

Working Conditions

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

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

• Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors
• Noise levels range from quiet to loud, depending on the work area
• Specific vision abilities, including near vision, visual acuity, and color discrimination

Personal Protective Equipment (PPE) is required and may include:

• Respirators, gloves, safety glasses, and full protective clothing
• Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)
• Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions

As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:

• Follow strict radiation safety procedures
• Participate in dosimetry monitoring and bioassay testing as part of the company protocol
• Inform leadership of any health conditions that may affect product integrity, by cleanroom standards

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.