Job Description

About Curium Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team. Summary of Position The Sterility Assurance Senior Manager is responsible for leading sterility assurance and contamination control efforts for support of new product development. The Sterility Assurance Manager will work cross-functionally to develop processes for the aseptic manufacture of parenteral drugs. This includes the following contamination control programs: clean room and isolator design and qualification, media fill programs, development of disinfection practices, environmental and critical utilities monitoring, gowning programs and the subsequent training of operators on the aseptic technique for the process, including OJT and Media Fill qualification. Author and Review SOP's, OJT's, Job Aids, Batch Records and Regulatory Submissions. Schedule: Monday Friday 8am 4:30pm Essential Functions Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.). Work cross functionally to coordinate testing schedules and communications in support of the weekly production activities and ensure QC testing and maintenance activities are completed per requirements. Ensure team compliance with all policies, procedures and site/company regulations. Work safely with radioactivity and ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals. Strong organizational and project management with the ability to juggle multiple projects/priorities. Strong technical writing skills. Assure compliance with department training and qualification. Requirements Bachelor of Science Degree in Chemistry, or other science related field required. 15 or more years of relevant experience required. 2 or more years of leadership experience in a cGMP environment. Lean Leader/Operational Excellence/5S preferred. Laboratory Instrument qualification preferred. Method validation/transfer preferred. Working Conditions: Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury. Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed. May be required to sit or stand for long periods of 8+ hours a day while performing duties. Must possess good hand-eye coordination; close attention to detail is required. Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants. Willingness to complete safety training within allotted timeframes, and work in a team-based environment. Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require. Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Equal Opportunity Employer Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Job Segment: Compliance, Forklift, Project Manager, Medical Technologist, Product Development, Legal, Manufacturing, Technology, Healthcare, Research Curium

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