GMP Manufacturing Night Shift Lead - Buffer & Compliance

Biopharma Careers; St. Louis (MO); On-site; USD 86,000 - 149,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma is seeking a GMP Manufacturing Support Supervisor - Night Shift at our Cherokee site in St. Louis to lead the GMP Operations Systems & Support team responsible for buffer manufacturing, equipment cleaning, training, compliance and material coordination.

You will oversee 12-hour night shifts, supervise production scientists and facility operators, drive cGMP adherence, continuous improvement, and cross-functional collaboration with QA, Materials, Engineering and Project Management.

Qualifications

• Bachelor’s Degree in Chemistry, Biology, Biochemistry or Life Science OR in Chemical/Mechanical Engineering or related field.
• 2+ years of life science manufacturing experience in a cGMP setting.
• 1+ year of Management, Supervisory, or Lead experience OR 6+ years of life science manufacturing experience with 1+ year of management.
• Relevant cGMP and regulatory requirements knowledge.

Responsibilities

• Lead production scientists and operators in scale-up, technology transfer, and execution of cGMP buffer manufacturing.
• Lead Facility Operators in maintaining cleanliness, equipment staging, waste disposal, and other manufacturing support tasks.
• Develop employees’ knowledge and skills and coordinate group efforts to meet objectives.
• Oversee manufacturing of processing aids and excipients regulated by FDA and others.
• Adhere to protocols established according to current Good Manufacturing Practices.
• Work cross-functionally with Project Management, Technical Operations, Process & Analytical Development, Quality Control, QA, Packaging, Materials Management, Engineering, and Maintenance.
• Interact with customers’ project management, technical and quality teams.
• Maintain departmental goals safely and in compliance with OSHA, EPA, FDA, EMA, etc.
• Manage capital for equipment and facility improvements and budget balancing.
• Support Process Improvement and company goals; revise procedures, batch records, and documentation.

Skills

Life science manufacturing experience

Leadership / supervisory

cGMP knowledge

Quality systems awareness

Cross-functional collaboration

Education

Bachelor’s Degree in Chemistry/Biology/Biochemistry/Life Science

Bachelor’s Degree in Chemical/Mechanical Engineering or related field

High School Diploma or GED

Job description

MilliporeSigma is seeking a GMP Manufacturing Support Supervisor - Night Shift at our Cherokee site in St. Louis to lead the GMP Operations Systems & Support team responsible for buffer manufacturing, equipment cleaning, training, compliance and material coordination.

You will oversee 12-hour night shifts, supervise production scientists and facility operators, drive cGMP adherence, continuous improvement, and cross-functional collaboration with QA, Materials, Engineering and Project Management.