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 Manager Production will work in a dynamic organization in the Operations team for North America. This role has the responsibility for supporting the on-time execution and delivery of sterile drug products including maintenance and reliability efforts. The Operations Manager will report to the Director of Operations.
This role also has the responsibility for supporting and implementing projects related to Curium's business strategy. More specifically, the responsibility and accountability of implementing New Product projects in support of Curium's growth strategy in the leading edge of radiopharmaceutical diagnostic and therapeutic sterile drug products designed for critical-to-life indications.
Work Schedule: 8am - 4:30pm
Essential Functions • Provide Manufacturing expertise, oversight and guidance
• Lead a team of direct reports
• Provide Aseptic Manufacturing expertise and guidance
• Support cross-functional teams
• Partner with Quality Leadership to ensure good quality and cGMP practices and execute Quality events
• Ensure manufacturing department is prepared to meet commercial demand
• Provide maintenance and reliability support
• 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.)
Requirements • Bachelor's degree in Chemistry, Engineering or related field
• Seven years' experience in pharmaceutical manufacturing with a minimum of five years of leadership experience
• Subject Matter Expert knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products
• Strong project management and organizational skills, including ability to work independently and as a team member
• Proven ability in setting priorities and organizing work to meet deadlines
• Proven experience in leading complex multi-discipline teams in a highly regulated environment
• Strong oral and written communication skills with proven ability to communicate effectively in high pressure environments
• Ability to react to problems and lead the team to develop solutions while communicating effectively
• Ability to maintain collaboration in a results-driven environment
• Agile approach and willingness to learn new things ability to work "on the fly" in a dynamic setting
• Experience with radiation safety programs preferred
• Lean and/or Six Sigma certification preferred
• Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project and Visio
• Travel may be required up to 5% of the time
Working Conditions: • Standard office environment, coupled with up to approximately 25% time in clean room, radiopharmaceutical manufacturing, and laboratory environments.
• Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
• 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.
• Willingness to work in a team-based environment.
• Close attention to detail required.
• May be required to stand or sit for long periods of time while performing duties. Must be able to stand 8+ hours a day.
• Responsibilities also include the ability to lift heavy objects (50 to 70 pounds), kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reach without accommodation.
• Must possess good hand-eye coordination.
• Must be able to work outside of regular work hours and extended hours, including off shift, weekend, and holiday work as business needs require.
• Willingness to complete safety training within allotted timeframes, and ensure direct reports trainings and goals are completed and up to date.
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.
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Job Tags
Work at office, Shift work,