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 (Contractor) Startup Manager will work in a dynamic organization for our Noblesville, Indiana site in 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 (Contractor) Startup Manager will report to the Director of Operations. This role has 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. Projects can include technical transfer, drug development, conceptual design, scoping and estimation, integration, etc. The (Contractor) Startup 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.

Essential Functions

• Support and/or lead large cross-functional projects and project teams through process evaluation, design, and implementation of robust processes
• 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.)
• Product start-up manager responsible for coordinating product launch activities
• Identify strategy, develop and execute startup plans
• Technical and operational oversight for startup teams
• 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
• Technical evaluation of new products relative to current site processes; process design for new products within existing or new manufacturing equipment

Requirements

• Bachelor degree in Chemistry, Engineering or related field
• 12 or more years of experience in pharmaceutical manufacturing with a minimum of two years of leadership experience.
• Experience as product start-up manager responsible for coordinating product launch activities
• Experience in optimization of processes, including establishment of process KPI's
• Strong project management and organizational skills, including ability to manage work of direct and indirect teams as well as provide individual contributions as a member of a larger team
• Experience with radiation safety programs preferred
• Subject Matter Expert knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products
• Ability to read PFDs and PIDs
• Knowledge of current industry practices and technologies
• 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

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.

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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