Manufacturing Supervisor at Curium Pharma in Maryland Heights, Missouri

Posted in Other 15 days ago.





Job Description:




Manufacturing Supervisor










Date:

Jun 9, 2021









Location:


Maryland Heights, MO, United States


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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 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.

Schedule:


  • Saturday - Wednesday (5 eight-hour shifts per week)

  • 5pm to 1:30 am

  • Ability to work overtime when necessary


Essential Functions



  • 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.


Requirements



  • 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.

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 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 with or 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.


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 anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.













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