Senior Radiopharmaceutical Manufacturing Specialist (2nd shift)

About the role

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. We are seeking a skilled professional to operate as a Subject Matter Expert (SME) across various aspects of radiopharmaceutical manufacturing.

Responsibilities

• Operate as Subject Matter Expert (SME) across various aspects of radiopharmaceutical manufacturing, including 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.
• Perform safety checks and routine inspection of the 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 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.
• 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.
• Monitor product quality to ensure compliance with standards and specifications by identifying and verifying appropriate materials, area conditions, and process for production.

Qualifications

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

Additional Information

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.