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Manufacturing Operations Manager

Date:  Jan 25, 2023
Location: 

Noblesville, IN, United States

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 Manufacturing Operations Manager will work in a dynamic organization in the Operations 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 Manufacturing Operations Manager will report to the Director of Operations. 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 Manufacturing Operations Manager act as a product start-up manager that will participate in coordinating activities between R&D, engineering, quality assurance, quality control, validation, and manufacturing up to and including commercial product launch. 

 

Work Schedule: Monday - Friday 7:00am - 4:00pm. Hours are subject to change to meet operation needs.

Essential Functions

  • Support large cross-functional projects and project teams.
  • Act as product start-up manager responsible for coordinating product launch activities.
  • Work collaboratively to quickly move projects from scoping to implementation.
  • Provide 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 resource hours and general project task tracking for adherence to project milestone goals.
  • Support and manage the new product line(s) after reaching commercial manufacturing.

Requirements

  • Bachelor 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.
  • 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.

 

Working Conditions:

  • Must handle average to heavy weight materials by hand.  Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, but use of proper lifting and movement techniques is necessary to prevent injury.
  • Must be able to physically negotiate stairs and evacuation ladders without accommodation, to wear and operate safety equipment, enter vessels, inspect equipment, drive forklifts.
  • 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 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.
  • 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 heavy objects (50 to 70 pounds), kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reach with or without accommodation.  
  • Must possess good hand-eye coordination.

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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