cGMP Manufacturing Supervisor - Rotating Shift

Sigma-Aldrich Manufacturing LLC•St. Louis, MO

8d•Onsite

About The Position

At MilliporeSigma, as the cGMP Manufacturing Supervisor – Rotating Shift at our 3300 South Second Ave / Cherokee site, will manage production personnel in the manufacture of products and many support functions outside of manufacturing. Job duties include: 12 hour rotating Day (6:00am - 6:30pm)/ Night (6:00pm - 6:30am) 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 oversee a manufacturing training team currently consisting of persons, on rotating shifts (Day and Night Shift). This position will oversee a manufacturing coordination team consisting of persons working Monday-Friday. Team responsibility includes material transfers from warehouse, material returns, and material consumptions. This position will have the primary purpose of ensure 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 to OSHA requirements. 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 discipline.
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 many support functions outside of manufacturing.
Oversee the manufacturing of Active Pharmaceutical Ingredients (API’s) regulated by the Food and Drug Administration and other regulatory bodies.
Provide guidance Monday – Friday for scientists engaged in production readiness, including batch record review, equipment procurement, material transfer, training oversight and employee scheduling.
Oversee a manufacturing training team currently consisting of persons, on rotating shifts (Day and Night Shift).
Oversee a manufacturing coordination team consisting of persons working Monday-Friday. Team responsibility includes material transfers from warehouse, material returns, and material consumptions.
Ensure 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.
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 to OSHA requirements.
Ensure tasks are done in accordance with approved site procedures, batch records and protocols.