CGMP Manufacturing Supervisor - Night Shift

Work Location:

St. Louis, Missouri

Shift: Yes

Department: LS-SC-UYKME Cherokee Manufacturing GMP 2

• 12 hour night shift (7:00pm - 7:30am) shifts with a 20% shift differential
• Oversee the manufacturing of Active Pharmaceutical Ingredients (API’s) regulated by the Food and Drug Administration and other regulatory bodies.
• This position will have direct reporting structures for scientists engaged in supporting the manufacturing operations, production coordinator, and manufacturing training program.
• Provide guidance Monday – Friday for scientists engaged in production readiness, including batch record review, equipment procurement, material transfer, training oversight and employee scheduling.
• This position will be overseeing a manufacturing training team currently consisting of people on rotating shifts (Day and Night Shift).
• This position will oversee a manufacturing coordination team consisting of people working Monday-Friday. Team responsibility includes material transfers from warehouse, material returns, and material consumptions.
• This position will have the primary purpose of ensuring goods receipts are performed in a timely manner after manufacturing campaign is complete.
• Lead a team of production scientists and operators in the scale-up, technology transfer, and execution of cGMP manufacturing.
• Develop employees’ knowledge and skills to improve performance and expand abilities as well as to coordinate the group’s efforts to assist meeting the departmental, company, and customer’s objectives.
• Adhere to protocols consistent with, and established according to, current Good Manufacturing Practices.
• Collaboration is important. Work cross-functionally with Project Management, MSAT, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance.
• Interact with our customers’ project management, technical and quality teams.
• Maintain departmental goals and objectives in a safe manner and in compliance with all applicable federal, state, and company regulations (OSHA, EPA, FDA, EMA etc.).
• Responsible for the management of capital for equipment and facility improvements, including balancing the departmental budget. A primary responsibility will be the creation of purchasing Process Orders.
• Support department efforts toward Process Improvement and company goals.
• Revise and approve procedures, batch records, and other documentation to ensure compliance with cGMP guidelines.
• Ensure employees remain current with all department and site training requirements.
• Assist and/or Lead root cause investigations and implement effective corrective and preventative actions related to manufacturing deviations.
• Provide leadership and support of safety initiatives within production operations to ensure compliance with OSHA requirements.
• Ensure tasks are done in accordance with approved site procedures, batch records and protocols.

• Bachelor’s Degree in Chemistry, Biology, Biochemistry, Chemical Engineering, or other Life Science disciplines.
• 4+ years of manufacturing experience in a cGMP setting.
• 1+ years of Management, Supervisory, or Lead experience.

• 3+ years of Management, Supervisory, or Lead experience in GxP environment.
• Customer interfacing audit experience.
• Knowledge of Six Sigma concepts/Lean Manufacturing or process improvement.
• Familiarity with large scale cGMP process equipment, tangential flow, and chromatography automation.
• Strong Microsoft Office experience for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports.
• Strong interpersonal skills and conflict resolution experience
• Advanced written…