***This role is a Second Shift role, Mon-Fri, 3pm to 11pm***

JOB SUMMARY

The Aseptic Manufacturing Supervisor is a hands-on, shop floor–based leader responsible for executing sterile drug product manufacturing operations in a cGMP environment. This role actively works alongside manufacturing technicians to ensure safe, compliant, and efficient aseptic processing. The Supervisor owns real-time operations on shift, drives adherence to aseptic practices and GMP documentation, and ensures production schedules are met through direct engagement on the floor.

Key Responsibilities

Shop Floor Leadership & Execution

Lead from the floor by actively overseeing and supporting aseptic processing operations throughout the shift.
Work directly alongside manufacturing technicians during setup, processing, interventions, and troubleshooting.
Serve as the primary point of contact on shift for operational decisions, issue escalation, and prioritization of work.
Assign tasks, monitor execution, and adjust resources in real time to meet production requirements.
Ensure proper equipment setup, line clearance, and adherence to validated processes at all times.
Respond to and manage abnormal conditions and events in real time to minimize impact to operations.

People Leadership

Supervise, coach, and develop Manufacturing Technicians (levels I 3) through direct, daily engagement on the floor.
Set clear expectations for performance, aseptic behavior, and GMP execution.
Conduct performance reviews, provide routine feedback, and support employee development.
Reinforce accountability and maintain a disciplined, high-performing team environment.

Compliance & Quality Ownership

Ensure strict adherence to cGMP requirements, aseptic technique, and safety standards.
Own the accuracy and completeness of all batch documentation generated on shift.
Identify, initiate, and support deviation and non-conformance investigations, ensuring timely and thorough resolution.
Maintain constant inspection readiness through proper execution and documentation practices.
Partner closely with Quality to ensure standards are understood and consistently applied on the floor.

Training & Aseptic Standards

Ensure all personnel are qualified and compliant with aseptic gowning and operational requirements.
Provide real-time coaching and reinforcement of proper aseptic behaviors and techniques.
Lead continuous development of team capability through cross-training and skills progression.
Actively observe operations to identify and correct at-risk behaviors immediately.

Operational Excellence & Continuous Improvement

Drive a culture of right-first-time execution and disciplined adherence to procedures.
Identify and implement improvements to enhance efficiency, reduce errors, and strengthen compliance.
Track and respond to key performance indicators (e.g., schedule adherence, deviations, right-first-time execution).
Provide input on equipment, processes, and materials to improve operational performance.

Communication & Shift Management

Provide clear and structured shift direction, priorities, and expectations at shift start.
Deliver detailed shift handovers, including status, issues, risks, and follow-up actions.
Communicate effectively with cross-functional teams (Quality, Engineering, Supply Chain, etc.).
Escalate issues appropriately with clear, concise information and proposed actions.

EDUCATION AND MINIMUM EXPERIENCE

Bachelor 27s degree in a scientific or technical field (or equivalent industry experience) preferred
5 38 years of experience in cGMP biopharmaceutical manufacturing
Prior experience in aseptic processing required
Previous leadership or supervisory experience in a manufacturing environment strongly preferred

Or equivalent combination of education and experience