Senior Manufacturing Science & Technology Engineer

Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team.

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, and customized radiopharmaceutical development services.

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, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

• Provide successful technology transfer, startup, and operation, partnering with Quality, Process Development, Engineering and Operations.
• When supporting operations in the CMO/CDMO business, works directly with Business Development to lead the development and execution of technical transfer plans for new products.
• Lead the development and execution of design transfer plans for new products and maintain process documentation for new and existing programs.
• Lead the preparation and execution of procedures, protocols, reports, and plans for assigned processes including factory and site acceptance testing and qualification activities in a radiological environment.
• Generate manufacturing batch records, recipes, workflows, and standard operating procedures, Work instructions, and logbooks, ensuring that operational data, configurations, processes, and reports meet all regulatory requirements
• Identify and lead efforts to improve or optimize manufacturing capacity/efficiency by analyzing and planning material and workflow, layouts/space requirements, and equipment to meet quality and production goals. Efficiently communicate to all levels of stakeholders during the process.
• Lead the creation and documentation of recommended maintenance strategies for relevant systems in collaboration with key stakeholders, applying risk-based decision-making practices and balancing performance, cost, and risk, including planning maintenance delivery tasks per system maintenance strategies and procedures.
• Lead, review, and investigate system/equipment failure incidents, formulate and record lessons learned, and continually improve and optimize system operation and maintenance strategies by implementing corrective and preventive actions.
• Lead and support the creation of risk assessments, gap analyses, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action and preventative action identification. Serve as a mentor to others in these processes across departments and functions.
• Provide production support for hot cells, automation equipment, and chemical/formulation, filling, and packaging processes in pharmaceutical clean room environments. Mentor others on these systems and equipment across departments and functions.
• Develop training programs and provide training on process systems and equipment.
• Display continuous improvement mindsets and behaviors to drive operational excellence.

Bachelor’s Degree in applicable Engineering field such as Mechanical, Industrial, Chemical or Nuclear or equivalent combination of education and experience and minimum four (4) years of experience in a life science, nuclear power, food processing, or medical device industry.

Preferred Experience:

Strong experience with FDA regulations, cGMP regulations, and pharmaceutical industry.  Working knowledge of Tech Transfer between Development and Manufacturing.

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.