Senior MSAT, CDMO

NorthStar Medical Radioisotopes•Beloit, WI

4d•Onsite

About The Position

The Senior MSAT, CDMO is a technical leader and subject matter expert responsible for complex technology transfer, process validation, scale-up, and commercial manufacturing. The role provides strategic technical direction, leads high-impact investigations and improvement efforts, and represents the organization in sponsor and regulatory interactions, audits, and inspections. It also supports organizational capability through technical mentorship, cross-functional leadership, and advancement of manufacturing excellence across multiple programs. The position supports process characterization, validation, continued process verification, commercial readiness, and product lifecycle activities. It provides technical oversight and troubleshooting support to manufacturing operations, guides investigations and quality-system records, manages complex technical projects, and leads continuous improvement initiatives. The role also develops and delivers training for Operations and provides on-the-floor and standby technical support as required. Work may take place in a controlled cleanroom, general office, or manufacturing areas. Conditions can include varying indoor and outdoor temperatures and noise levels from quiet to loud. PPE may include respirators, gloves, safety glasses, and full protective clothing. Cleanroom gowning requirements prohibit jewelry, cosmetics, fragrances, and nail products. Radiation may be present in laboratory and production areas; the role must follow radiation safety procedures and may require dosimetry monitoring and bioassay testing.

Requirements

Bachelor’s degree in a relevant STEM field and at least six years of relevant technical experience in technology transfer, product development, process validation, or commercial manufacturing in a regulated industry and/or medical or 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.
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.
Ability to comply with cleanroom gowning and radiation safety procedures; the role may require dosimetry monitoring and bioassay testing.

Nice To Haves

Experience with radiopharmaceutical process development, upstream processing, downstream processing, or fill-finish operations.
Experience managing cross-functional technical projects and delivering complex programs in a fast-paced manufacturing environment.
Lean Six Sigma Green Belt or higher certification.

Responsibilities

Serve as a technical lead for technology transfer, commercialization, manufacturing scale-up, and product lifecycle activities from development through commercial manufacturing.
Provide technical oversight to manufacturing operations and lead troubleshooting to support safe, compliant, and effective process execution.
Establish and maintain standards for technical documentation, including protocols, reports, batch records, and process descriptions.
Evaluate process performance, identify systemic improvement opportunities, and recommend long-term strategies to improve process robustness and operational efficiency.
Lead investigations involving deviations, non-conformances, manufacturing events, and out-of-specification results, including data gathering, risk assessment, and root cause analysis.
Contribute to and review change controls, CAPAs, and quality-system records for technical accuracy and compliance.
Align cross-functional activities among Manufacturing, Quality, Product Development, Validation, and other groups to support manufacturing needs.
Provide guidance and technical leadership for process characterization studies, validation, continued process verification, and commercial readiness activities.
Act as the primary subject matter expert during sponsor or regulatory interactions, audits, and inspections.
Manage complex technical projects, including risks, priorities, schedules, and technical deliverables.
Mentor and develop MSAT team members through technical coaching, knowledge transfer, and development guidance.
Lead continuous improvement initiatives using Lean, root cause analysis, and operational excellence methodologies.
Develop training programs and train Operations on manufacturing processes and equipment.
Provide on-the-floor and standby (on-call) technical support to manufacturing as required.
Perform duties in compliance with safety and regulatory standards, including cGMP/FDA, OSHA, DOT, and Wisconsin DHS requirements.