Manager Production

The Production 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 Production Manager will report to the Site Director. 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 Production 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.

• 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.
• 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 Degree in Chemistry, Engineering or related field.
• 12 or more years of relevant 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:

• 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.