Pay Range:

Position Summary:

The Manufacturing Supervisor leads daily operations in a GMP-regulated production environment, supporting the filling, capping, labeling, and inspection of antibodies, proteins, enzymes, and kit components. This role ensures compliance with quality systems while driving safety, efficiency, and on-time delivery. The supervisor oversees team performance, supports technical troubleshooting, and partners cross-functionally to optimize production processes.

Key Responsibilities:

• Supervise and develop production staff to meet safety, quality, and throughput targets

• Ensure adherence to SOPs, GMP/GDP standards, ISO requirements, and documentation practices

• Oversee product processing, including vial/bottle preparation, aseptic filling (pipetting), capping, labeling, and visual inspection

• Operate and troubleshoot production equipment (e.g., automated vial torquing and labeling systems)

• Support laminar flow hood operations and cleanroom gowning procedures

• Perform or verify production calculations (e.g., volume, concentration, yield)

• Maintain accurate batch records, inventory transactions, and ERP system data

• Coordinate priorities with Planning, Quality, Engineering, and Materials teams

• Investigate deviations, support CAPA activities, and resolve non-conformances

• Maintain training programs, skills matrices, and cross-training initiatives

• Monitor and report on production metrics (safety, quality, delivery, efficiency)

• Participate in continuous improvement efforts (Lean, waste reduction, process optimization)

• Support new product introductions, process transfers, and lyophilization activities

• Approve timecards and manage staffing to meet production demands

• Perform additional duties as assigned

QUALIFICATIONS

Education and Experience:

• Bachelor’s Degree in Science or Engineering or equivalent experience

• 3+ years of manufacturing experience in a regulated environment (GMP/ISO preferred)

• Demonstrated leadership capacity required; previous supervisory experience preferred

• Working knowledge of manufacturing regulatory compliance requirements

• Formal continuous improvement training and experience desirable (Lean/ Six Sigma)

Knowledge, Skills, and Abilities:

• Working knowledge of GMP, GDP, and ISO quality systems

• Experience with aseptic technique, pipetting, and cleanroom operations

• Familiarity with laboratory and production equipment, including automated filling, torquing, or labeling systems

• Ability to perform and verify calculations related to concentrations, dilutions, and volumes

• Strong troubleshooting and root cause analysis skills

• Proficiency with ERP/MRP systems and Microsoft Excel

• Strong attention to detail and documentation accuracy

• Ability to lead, coach, and communicate effectively in a team environment

• Ability to manage multiple priorities in a fast-paced production setting

Working Conditions:

• Work performed in a laboratory and production environment with exposure to chemicals, reagents, and standard lab equipment.

• Minimal or no travel required.

Physical Requirements:

• Ability to lift and handle materials weighing 5–50 lbs.

• Ability to stand, walk, and perform repetitive laboratory tasks for extended periods.

• Manual dexterity required for laboratory equipment and fine measurement techniques.