Posted on 31st July 2019
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 Manufacturing Supervisor is responsible for the oversight of manufacturing operations associated with the manufacturing of radiopharmaceuticals which meet approved specifications by supervising from the floor, coaching and developing their team, and ensuring that their area of operations maintains compliance with Corporate policies, and local and federal regulations. The supervisor is responsible for fostering a culture of team ownership, transparency, team success.
- Saturday – Wednesday (5 eight-hour shifts per week)
- 7 pm to 3:30 am
- Ability to work overtime when necessary
- Demonstrates an ability to lead in a fast paced environment in regards to production goals, standards, mindsets and behaviors both on and off the production floor.
- Ensures strict adherence to quality, safety, regulatory and written procedures in the manufacture of products in accordance with OSHA and CFR (cGMP) guidelines.
- Ensures vigilance to the production schedule to meet customer demands and reduce overtime (ensure most effective and efficient use of personnel, materials and time).
- Demonstrates a willingness to be flexible and adaptable to the needs of the department and business.
- Takes ownership and is an active member with continuous improvement activities including: reliability team meetings, root cause analysis, SOP and Batch record improvements, Kaizen events, and Customer Complaints.
- Ensures the maintenance and cleanliness of department, premises and equipment.
- Performs the Review of Batch Records and maintain all documentation according to SOPs and cGMP Guidelines.
- Monitors product quality to ensure compliance with standards and specifications.
- Participates and performs effectively in a team environment and interact with multiple departments to ensure the operational success of the team.
- Follows all written procedures and verbal instructions and communicate effectively, both written and verbally.
- Identifies and verifies appropriate materials, area conditions, process for production are met, and address any abnormalities in the process, with collaboration with Quality and leadership.
- Takes full ownership and accountability of personnel, equipment, process and area assigned to or related to production process.
- Uses logical methods to solve difficult problems with effective solutions and is able to makes sound decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick quality decision.
- Must be willing to attend additional training/schooling when required.
- Bachelor Degree or completion of an equivalent certification program from a technical or vocational school is required. Equivalent relevant years of experience in this field will also be considered.
- Minimum of five years of proven work experience in a regulated manufacturing environment with a minimum of two years of supervisory experience.
- Experience working in a FDA cGMP regulated environment with Quality Systems is required.
- Strong mechanical aptitude is required, scientific background is preferred.
- Must be capable of providing front line troubleshooting of manufacturing equipment and process issues, properly elevating concerns and issues to appropriate personnel.
- 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 up to 70 pounds, walk, bend, stoop, kneel, crouch, crawl, twist upper body, push, pull, reach, and climb stairs and ladders without accommodation.
- Must be willing to wear a variety of personal protective equipment.
- May be required to sit or stand for long periods of time while performing duties.
- Must be able to work outside of regular work hours, work rotating shifts, weekends, and overtime, as necessary.
- Willingness to work around mechanical and moving parts, around low and high voltages, with exposure to dust, dirt, odors and irritants.
- Close attention to detail required, and must possess good hand-eye coordination.
- Willingness to work in a team-based environment.
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.