Buffer Manufacturing Team Lead - Night Shift

About the role

The Buffer Manufacturing Team Lead - Night Shift at MilliporeSigma oversees and guides Manufacturing Scientists and Technicians in the preparation and manufacturing of buffers and solutions. This role requires a proactive approach to identifying and resolving issues while fostering a positive and collaborative work environment.

Responsibilities

• Shift details: Supports 24/7 manufacturing operations and works 12-hour shifts from 6PM – 6:30 AM with 20% shift differential.
• Lead the buffer formulation team in the execution of cGMP buffer manufacturing.
• Evaluate products according to established protocols, provide technical support to others, and perform operations in support of the group and department.
• Safely perform operations to meet quality expectations.
• Maintain required training to perform tasks/assignments.
• Perform routine processes and unit operations.
• Clean equipment and working areas during and after operations.
• Support facility functions (e.g., maintain equipment, prepare reagents, restock supplies, waste disposal).
• Aid in Buffer formulation schedule and communication with ADC.
• Revise and approve procedures, batch records, and other documentation to ensure compliance with cGMP guidelines.
• Communicate the status of operations and convey concerns to the supervisor.
• Provide complete and accurate records consistent with quality guidelines.
• Ensure all applicable logbooks are completed as required by current procedures.
• Help with MMF review.
• Participate as needed in quality audits and customer interactions.
• Improve processes by applying scientific knowledge, experience, and principles, in compliance with change control.
• Take action to resolve unsafe conditions.
• Train team members and act as technical consultants.

Requirements

• Lift up to 35 lb.
• Personal protective equipment such as a respirator or chemical protective clothing for extended periods.

Qualifications

• Minimum Qualifications: Bachelor’s Degree in Chemistry, Biochemistry, Biology, or other scientific discipline with 2+ years of experience in GMP manufacturing or operations, in a pharmaceutical or biotechnology environment. OR High School Diploma or GED with 4+ years’ experience in GMP manufacturing, in a pharmaceutical or biotechnology environment.
• Preferred Qualifications: Excellent problem-solving abilities and a proactive approach to identifying and resolving issues, both process and mechanical. Knowledge of process techniques, unit operations, and safe chemical handling methods. Familiarity with regulatory requirements and industry best practices related to GMP manufacturing, including ICH regulatory and Quality standards. Proficient in SAP, Microsoft Office and other software applications. Strong leadership and interpersonal skills, with the ability to motivate and guide a diverse team. Knowledge of Lean Manufacturing principles and continuous improvement methodologies (OpEx).

Skills

• Problem-solving abilities.
• Proactive approach to identifying and resolving issues.
• Process and mechanical knowledge.
• Regulatory requirements and industry best practices.
• SAP, Microsoft Office, and other software applications.
• Leadership and interpersonal skills.
• Lean Manufacturing principles and continuous improvement methodologies.

Benefits

• Health insurance.
• Paid time off (PTO).
• Retail contributions.
• Other perquisites.