Posted on 7th February 2019
Operations Manager – New Product Initiatives
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.
Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.
At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”. We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration. Come grow with us!
Summary of Position
The Operations Manager will work in a dynamic organization in the New Product Initiatives (NPI) team for North America. This role has the responsibility for supporting and implementing projects related to Curium’s business strategy in the space of sterile drug manufacturing including reactor and cyclotron derived new products. The Operations Manager will report to the Director of New Product Initiatives. This role will help support activities associated with New Product Development, BD&L, M&A, PMO, and CMO activities. Projects can include technical transfer, drug development, conceptual design, scoping and estimation, integration, etc. The Operations Manager will be responsible for coordinating activities between R&D, engineering, quality assurance, quality control, validation, and manufacturing up to and including commercial product launch.
- Support and/or lead large cross-functional projects and project teams
- Act as product start-up manager responsible for coordinating product launch activities
- Work collaboratively with Project Manager to quickly move projects from scoping to implementation
- Provide Aseptic Manufacturing expertise and guidance of evaluation and design of new processes
- Partner with Quality Leadership to ensure good quality and cGMP practices and their implementation in new product launch
- Ensure manufacturing department is prepared to meet commercial demand once product is launched
- Provide and maintain forecast estimates for project related costs, resource hours, and general project task tracking for adherence to project milestone goals
- Bachelor’s degree in Chemistry, Engineering or related field
- Seven years’ experience in pharmaceutical manufacturing with a minimum of five years of leadership experience.
- Strong project management and organizational skills, including ability to work independently and as a team member
- Experience with radiation safety programs preferred
- Subject Matter Expert knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products
- Familiar with project management tools and best practices
- Proven ability in setting priorities and organizing work to meet deadlines
- Technical understanding of the pharmaceutical development process from concept to launch
- Proven experience in leading complex multi-discipline project 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 to the executive team
- 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
- Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project and Visio
- Travel may be required up to 5% of the time
- Experience managing projects with Smartsheet (preferred but not required)
- Lean and/or Six Sigma certification preferred
- Standard office environment, coupled with up to approximately 25% time in clean room, radiopharmaceutical manufacturing, and laboratory environments.
- Must be willing to wear a variety of personal protective equipment.
- 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 also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
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.
Posted on 15th May 2019
Posted on 15th May 2019