Manager Production

The Manufacturing Operations Manager 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

*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.)

*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.