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 PositionThe Lead Manufacturing Technician is responsible for leading the operations associated with the manufacturing of a radioactive drug product which meets site specifications, by leading from the floor in the areas of clean up, set up, and operation of equipment by trained and qualified personnel. Areas of operation to include formulation, dispensing, packaging, and release of final drug product. This position is also responsible for support activities such as maintenance and disinfection.Work schedule: Monday - Friday 8:00am - 4:30pm. Schedule could be adjusted. Ability to work overtime when necessary.
Essential Functions - Support all aspects of the sterile drug manufacturing operation under area of responsibility including but not limited to: Production, Maintenance, Safety,
- Environmental, Quality, Service, Budgeting, Cost Reduction Programs, Process Improvements, Special Projects, and Employee Relations.
- Responsible for seeing that all tasks are performed in a manner that complies with Noblesville Quality Management System, Safety and Environmental Management System, and all governing regulatory bodies.
- Partner with quality/safety leadership to ensure good quality/safety practices are aligned with production.
- Coach and develop Manufacturing Technicians and Operations Team members.
- Responsible for driving creation and implementation of Cost Reduction Programs.
- Lead and drive Continuous Improvement philosophy and practices including but not limited to Six Sigma, Lean Manufacturing, TPM, SMED, 6S, and OEE throughout the focus factory.
- Responsible for monitoring daily/ weekly production schedules and changes.
- Responsible for all special projects assigned by the Production Manager to include but not limited to Lean Manufacturing initiatives, six sigma projects, safety initiatives, etc.
- Maintain specified product quantity levels, including raw materials, and product specifications.
- Set clear vision by ensuring tactical goals and objectives are aligned with site strategies through performance management for each team member.
- Lead and/or support investigations, manufacturing exceptions, product failures, RCA, and customer complaints at the appropriate level with complete and comprehensive detail.
- 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.).
Requirements - High school diploma or GED equivalent is required. Associate degree is preferred.
- Six or more years of relevant work experience in manufacturing required (regulated environment, attention to detail, and following detailed instructions).
- Experience in a Lead/Supervisory role preferred.
- Ability to work flexible hours.
- Occasional travel (less than 10%) to other manufacturing locations.
- Six Sigma Green Belt/Lean Certification preferred.
- Lean tools, Regulatory Compliance knowledge, Excel, Word, and PowerPoint.
- Exemplary team building behavior and a proven collaborative attitude.
- Strong mechanical aptitude as well as scientific background.
- Able to provide front line troubleshooting of equipment/process issues.
- Thorough understanding of the needs of internal/external customers and ensuring customer satisfaction a top priority.
- Capable of adjusting to changes and dealing effectively with uncertainties in the workplace.
- Experience generating new and valuable ideas and effective solutions to difficult problems; connecting previously unrelated notions.
- Strong motivation and ability to achieve work goals and quantifiable business results.
- Willingness to help outside your department and within your department outside your normal or assigned responsibilities.
- Demonstrated willingness to be flexible and adaptable to the needs of the department and business.
- Knowledge of Good Manufacturing Practices c(GMP)'s and applicable Quality System Standards.
- Willingness to work rotating shifts, weekends, and overtime, as necessary.
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.Job Segment: Maintenance, Lean Six Sigma, Six Sigma, Compliance, Medical Technologist, Manufacturing, Management, Legal, Healthcare