Supervisor Production

The Maryland Heights Hot API (Active Pharmaceutical Ingredient) Focus Factory produces bulk radioactive material that is used in finished formulation manufacturing processes of other areas in the Maryland Heights facility. A Supervisor of Production at our Maryland Heights facility is responsible for ensuring accountability, transparency, and effective communication cross-functionally and within his/her team while ensuring information is timely, clear, and accurate. By coaching and developing his/her team to High Performance, he/she will foster a culture of team ownership that ensure compliance with all Corporate and Local policies, procedures, and regulations.

While supervising in a cGMP environment, he/she must maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, HC, TGA, EU, NRC, BDB, DHSS, etc.). In addition, he/she must supply the highest level of both internal and external customer service. To effectively recognize and reward performance, the supervisor must measure and communicate the team's progress against individual, team, and site goals and Key Performance Indicators (KPIs).

The Hot API Production Supervisor is responsible for supervising the operations associated with the manufacturing of a several key operations by supervising from the floor in the areas of clean up, set up, and operation of equipment by trained and qualified personnel. This position is also responsible for support activities such as maintenance.

Work Schedule:

The standard shift hours covered by this position are Saturday - Wednesday 8:30 pm to 6:00 am with overtime as required to ensure timely release of products. Hours are subject to change.

• Support all aspects of Hot API Focus Factory operations under area of responsibility including but not limited to Safety, Environmental, Quality, Scheduling, Budgeting, Process Improvements, Special Projects and Employee Relations.
• Responsible for seeing that all tasks are performed in a manner that complies with Maryland Heights Quality Management System, Safety and Environmental Management System, and all governing regulatory bodies. Ensure proper coverage of production and to support process improvements.
• Lead, coach, and train employees toward team concepts and foster an empowering and high performing environment.
• Ensure all direct reports are properly trained in areas directly related to their job responsibilities as well as company policies, quality policies, and safety/environmental policies.
• Communicates issues appropriately utilizing the area's escalation plan.
• Spend 70% of your time on the production floor directly with employees and processes.
• Ensure accountability, transparency, and effective communication cross-functionally and within the team while guaranteeing information is timely, clear, and accurate.
• Set clear vision by ensuring goals and objectives are aligned with site strategies through performance management for each team member.
• Provide input on equipment installation, start-up, operation, and troubleshooting.
• Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
• Lead and/or support all investigations, manufacturing exceptions, product failures, Root Cause Analyses, and customer complaints at the appropriate level with complete and comprehensive detail.
• Author, approve, and/or review all area quality and safety exceptions and investigation reports. Ensure on time completion of all corrective action items assigned to area.
• Manage the department's overtime and ensure that all payroll exception reports are completed and submitted on time.
• Lead team in continuous improvement activities and take control when faced with adversity while incorporating team input.
• 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 of Science degree in Manufacturing, Engineering, or related field required. Work experience considered in lieu of degree.
• Ten or more years of relevant work experience required, including experience in a cGMP environment required, preferably in manufacturing.
• Two or more years of supervisory experience is required.
• Lean/Kaizen/Six Sigma experience preferred. Lean tools, Regulatory Compliance knowledge, Excel, Word, and PowerPoint.
• Coaching & Implementing Autonomous Maintenance activities preferred.
• Experience with developing/documenting procedures required.

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.