GMP Manufacturing Support Supervisor-Day Shift

The businesses of Merck KGaA, Darmstadt, Germany•St. Louis, MO

53d•$85,700 - $149,400•Onsite

About The Position

This role will support 24/7 manufacturing operations and work 12-hour shifts from 6:00am – 6:30pm including a 5% shift differential. At MilliporeSigma, the GMP Manufacturing Support Supervisor -Day Shift at our Cherokee site/3300 S. Second Ave, St Louis, will play a key role within our GMP Operations Systems & Support team. This team supports Manufacturing through various functions including buffer manufacturing, training, compliance, equipment and facility cleaning, and raw material coordination. Expectations of the GMP Operations System & Support team are to ensure compliance and readiness within our GMP Manufacturing teams, ultimately enabling high manufacturing success. The supervisor will lead production scientists and operators in the scale-up, technology transfer, and execution of cGMP buffer manufacturing. They will also lead Facility Operators in supporting Manufacturing through maintaining cleanliness of manufacturing facilities and equipment, staging of equipment and supplies, waste disposal, and other various manufacturing support activities. The role involves developing employees’ knowledge and skills to improve performance and expand abilities as well as coordinating the group’s efforts to assist meeting the departmental, company, and customer’s objectives. The supervisor will oversee the manufacturing of processing aids and excipients, regulated by the Food and Drug Administration and other regulatory bodies. Adherence to protocols consistent with, and established according to, current Good Manufacturing Practices is required. The role requires working cross-functionally with Project Management, Technical Operations, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance, and interacting with our customers’ project management, technical and quality teams. The supervisor is responsible for maintaining departmental goals and objectives in a safe manner and in compliance with all applicable federal, state, and company regulations (OSHA, EPA, FDA, EMA etc.). They will also be responsible for the management of capital for equipment and facility improvements, including balancing the departmental budget. 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. 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 Chemistry, Biology Biochemistry or other Life Science field OR in Chemical Engineering, Mechanical Engineering or other Engineering fields AND 2+ years of life science manufacturing experience in a cGMP setting AND 1+ year of Management, Supervisory, or Lead experience
OR
High School Diploma or GED AND 6+ years of life science manufacturing experience in a cGMP setting AND 1+ year 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 buffer manufacturing, facility and equipment cleaning, and raw material management
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, conflict resolution experience, written, and verbal communication skills

Responsibilities

Lead production scientists and operators in the scale-up, technology transfer, and execution of cGMP buffer manufacturing.
Lead Facility Operators in supporting Manufacturing through maintaining cleanliness of manufacturing facilities and equipment, staging of equipment and supplies, waste disposal, and other various manufacturing support activities.
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.
Oversee the manufacturing of processing aids and excipients, regulated by the Food and Drug Administration and other regulatory bodies.
Adhere to protocols consistent with, and established according to, current Good Manufacturing Practices.
Work cross-functionally with Project Management, Technical Operations, 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.
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.
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.