cGMP Manufacturing Supervisor - Night Shift

Merck•Saint Louis, MO

17h•Onsite

About The Position

At MilliporeSigma, as the cGMP Manufacturing Supervisor – Night Shift at our 3300 South Second Ave / Cherokee site, you will manage production personnel in the manufacture of products and many support functions outside of manufacturing. This role involves overseeing the manufacturing of Active Pharmaceutical Ingredients (API’s) regulated by the Food and Drug Administration and other regulatory bodies. You will have direct reporting structures for scientists engaged in supporting manufacturing operations, a production coordinator, and the manufacturing training program. This position will provide guidance Monday – Friday for scientists engaged in production readiness, including batch record review, equipment procurement, material transfer, training oversight, and employee scheduling. You will oversee a manufacturing training team currently consisting of people on rotating shifts (Day and Night Shift) and a manufacturing coordination team consisting of people working Monday-Friday. The team responsibility includes material transfers from warehouse, material returns, and material consumptions. A primary purpose of this position is ensuring goods receipts are performed in a timely manner after a manufacturing campaign is complete. You will lead a team of production scientists and operators in the scale-up, technology transfer, and execution of cGMP manufacturing. You will develop employees’ knowledge and skills to improve performance and expand abilities, as well as coordinate the group’s efforts to assist in meeting departmental, company, and customer’s objectives. Adherence to protocols consistent with, and established according to, current Good Manufacturing Practices is essential. Collaboration is important, and you will work cross-functionally with Project Management, MSAT, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance. You will interact with our customers’ project management, technical, and quality teams. You will 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.). You will be 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. You will support department efforts toward Process Improvement and company goals. You will revise and approve procedures, batch records, and other documentation to ensure compliance with cGMP guidelines. You will ensure employees remain current with all department and site training requirements. You will assist and/or lead root cause investigations and implement effective corrective and preventative actions related to manufacturing deviations. You will provide leadership and support of safety initiatives within production operations to ensure compliance with OSHA requirements. You will ensure tasks are done in accordance with approved site procedures, batch records, and protocols.

Requirements

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.

Nice To Haves

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 and verbal communication skills.

Responsibilities

Manage production personnel in the manufacture of products and support functions.
Oversee the manufacturing of Active Pharmaceutical Ingredients (API’s) regulated by the Food and Drug Administration and other regulatory bodies.
Provide guidance for scientists engaged in production readiness, including batch record review, equipment procurement, material transfer, training oversight, and employee scheduling.
Oversee a manufacturing training team and a manufacturing coordination team.
Ensure goods receipts are performed in a timely manner after manufacturing campaign completion.
Lead a team of production scientists and operators in scale-up, technology transfer, and execution of cGMP manufacturing.
Develop employees’ knowledge and skills to improve performance and expand abilities.
Coordinate group efforts to meet departmental, company, and customer objectives.
Adhere to protocols consistent with current Good Manufacturing Practices.
Collaborate cross-functionally with Project Management, MSAT, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance.
Interact with 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.).
Manage capital for equipment and facility improvements, including balancing the departmental budget.
Create 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.