GMP Manufacturing Support Supervisor-Night Shift

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

Your Role:

At MilliporeSigma, the GMP Manufacturing Support Supervisor -Night 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. Job duties include:

• Shift Details: This role will support 24/7 manufacturing operations and work 12-hour shifts from 6:00pm – 6:30am including a 20% shift differential
• 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.

Physical Attributes

• Stand for extended periods of time
• Lift, push, and or pull up to 35lbs.
• Wear mask, safety shoes, gloves, Tyvek suits, respirator, and related personal protective equipment

Who You Are

Minimum Qualification

• Bachelor’s Degree Chemistry, Biology Biochemistry or other Life Science field OR in Chemical Engineering, Mechanical Engineering or other Engineering fields
• 2+ years of life science manufacturing experience in a cGMP setting
• 1+ year of Management, Supervisory, or Lead experience
• OR
• High School Diploma or GED
• 6+ years of life science manufacturing experience in a cGMP setting
• 1+ year of Management, Supervisory, or Lead experience

Preferred Qualifications

• 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
• RSREMD

Pay Range for this position

$85,700.00 - $149,400.00

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information .

Benefits

• Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.
• Position may be eligible for sales or performance-based bonuses.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!