Senior MSAT, CDMO

NorthStar Medical Technologies; Beloit (WI); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

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.

Join our MSAT team to lead technology transfer, process validation, investigations, and continuous improvement while collaborating with Manufacturing, Quality, and Product Development to enable commercial readiness.

Formación

• Bachelor’s degree in a relevant STEM field with ≥6 years in regulated manufacturing.
• Experience supporting manufacturing programs in pharma/biotech.
• Knowledge of Lean manufacturing and continuous improvement principles.
• Familiarity with regulatory audits/inspections and cGMP practices.

Responsabilidades

• Serve as technical lead for technology transfer, scale-up, and product lifecycle activities.
• Provide technical oversight to manufacturing operations and lead troubleshooting.
• Lead investigations for deviations and out-of-spec results with root cause analysis.
• Contribute to change controls, CAPAs, and quality system records.
• Collaborate with Manufacturing, Quality, Product Development, Validation and others.
• Provide guidance for process characterization, validation, and continued process verification.
• Act as SME during sponsor/regulatory interactions, audits, or inspections.
• Manage complex projects with risks, timelines, and deliverables; mentor MSAT teammates.
• Lead continuous improvement initiatives using Lean and RCA methodologies.

Conocimientos

Safety communication

Technical leadership

Cross-functional collaboration

Problem solving

Risk assessment

Lean / continuous improvement

Training / mentorship

Educación

Bachelor’s degree in a relevant STEM field

Descripción del empleo

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.

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• Serve as a technical lead for technology transfer, commercialization, manufacturing scale-up, and product lifecycle activities from development through commercial manufacturing
• Provide strong technical oversight to manufacturing operations and lead troubleshooting activities to ensure safe, compliant, and effective process execution.
• Establish and maintain standards for technical documentation including protocols, reports, batch records, and process descriptions.
• Conduct advanced technical evaluations of process performance, identify systemic improvement opportunities, and recommend long-term optimization strategies to improvements process robustness and operational efficiency.
• Lead investigations including deviations, non-conformances, manufacturing events, and out-of-specification results by gathering data and performing risk assessments or root cause analysis.
• Contribute to and review change controls, CAPAs, and quality system records to ensure technical accuracy and compliance.
• Build alignment amongst cross-functional activities among Manufacturing, Quality, Product Development, Validation, and other functional groups to support manufacturing needs.
• Provide guidance and technical leadership for process characterization studies, validation activities, continued process verification efforts, and commercial readiness activities.
• Act as the primary SME during sponsor or regulatory interactions, audits, or inspections.
• Manage complex technical projects, managing risks, priorities, schedules, and technical deliverables to achieve business objectives.
• Mentor and develop other MSAT team members by providing technical coaching, knowledge transfer, and development guidance while influencing organizational capability without direct authority.
• Lead continuous improvement initiatives utilizing Lean, root cause analysis, and operational excellence methodologies.
• Develop training programs and provide training to Operations on manufacturing processes and equipment.
• Provide on-the-floor and standby (on-call) technical support to manufacturing as required.
• Perform all duties and responsibilities in compliance with safety and regulatory standards (e.g., cGMP/FDA, OSHA, DOT, WI DHS, etc.).
• Exhibit the behaviors and core values that support NorthStar’s Mission
• Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures

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.

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• Serve as a technical lead for technology transfer, commercialization, manufacturing scale-up, and product lifecycle activities from development through commercial manufacturing
• Provide strong technical oversight to manufacturing operations and lead troubleshooting activities to ensure safe, compliant, and effective process execution.
• Establish and maintain standards for technical documentation including protocols, reports, batch records, and process descriptions.
• Conduct advanced technical evaluations of process performance, identify systemic improvement opportunities, and recommend long-term optimization strategies to improvements process robustness and operational efficiency.
• Lead investigations including deviations, non-conformances, manufacturing events, and out-of-specification results by gathering data and performing risk assessments or root cause analysis.
• Contribute to and review change controls, CAPAs, and quality system records to ensure technical accuracy and compliance.
• Build alignment amongst cross-functional activities among Manufacturing, Quality, Product Development, Validation, and other functional groups to support manufacturing needs.
• Provide guidance and technical leadership for process characterization studies, validation activities, continued process verification efforts, and commercial readiness activities.
• Act as the primary SME during sponsor or regulatory interactions, audits, or inspections.
• Manage complex technical projects, managing risks, priorities, schedules, and technical deliverables to achieve business objectives.
• Mentor and develop other MSAT team members by providing technical coaching, knowledge transfer, and development guidance while influencing organizational capability without direct authority.
• Lead continuous improvement initiatives utilizing Lean, root cause analysis, and operational excellence methodologies.
• Develop training programs and provide training to Operations on manufacturing processes and equipment.
• Provide on-the-floor and standby (on-call) technical support to manufacturing as required.
• Perform all duties and responsibilities in compliance with safety and regulatory standards (e.g., cGMP/FDA, OSHA, DOT, WI DHS, etc.).
• Exhibit the behaviors and core values that support NorthStar’s Mission
• Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures

MINIMUM EDUCATION/EXPERIENCE

• Bachelor’s degree in a relevant STEM field with a minimum of six (6) years relevant technical experience (technology transfer, product development, process validation, or commercial manufacturing) in a regulated industry and/or medical/pharmaceutical manufacturing environment; or an equivalent combination of education and experience.
• Experience supporting manufacturing programs within a CDMO, biopharmaceutical, biotechnology, or pharmaceutical environment.
• Working knowledge of regulatory requirements and industry guidance, with experience supporting sponsor audits and regulatory inspections.
• Demonstrated ability to influence without direct authority, manage competing priorities, and build collaborative relationships across the organization.
• Knowledge of Lean manufacturing, continuous improvement methodologies, and operational excellence principles.

PREFERRED EDUCATION/EXPERIENCE

• Experience with radiopharmaceutical process development, upstream processing, downstream processing, or fill-finish operations.
• Demonstrated experience managing cross-functional technical projects and delivering complex programs in a fast-paced manufacturing environment.

PREFERRED CERTIFICATIONS

• Lean Six Sigma Green Belt or higher certification

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.