Position Summary:
The Lead Manufacturing Associate is responsible for performing upstream and downstream processing of bulk intermediates and/or bulk substances for biopharmaceutical products including seed expansion, bioreactor operations, cell harvest, chromatography, tangential flow filtration, viral inactivation, and bulk fill operations. With direct supervision, this individual will provide direction/guidance to Manufacturing Associates and Senior Manufacturing Associates ensuring Safety, Quality, and Delivery always. This position is for a 2-2-3 pitman day shift schedule starting at 6:00 AM to 6:30 PM.
Responsibilities:
- Manufacture product per established documentation in compliance with quality standards, company policies, and current regulations.
- Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
- Lead shift through pre-execution and post-execution review of their records as well as reviewing batch records real-time and elevating when appropriate.
- Demonstrate, apply, and ensure understanding of Good Manufacturing Practices with self and teammates.
- Assign shift tasks adhering to schedule requirements.
- Ensure Right-First-Time execution.
- Ensure additional tasks assigned by Manager/Supervisor are completed.
- The Lead Manufacturing Associate must be able to provide direction/guidance to Manufacturing Associates and Senior Manufacturing Associates; as well as to provide detailed status of processes and equipment to other staff members. The Lead Manufacturing Associate must fill in when the Manufacturing Supervisor is not available.
Requirements:
- Bachelor’s degree in a related scientific discipline with 6+ years’ experience in related GMP manufacturing operations OR a high school diploma with 10+ years’ experience in related GMP manufacturing operations.
- Motivated, approachable, and looking to lead by example is required.
- Continuous improvement, Right-First-Time mentality is required.
- Knowledge of Upstream (Cell Culture or Fermentation) or downstream (Purification and Bulk Fill) operations is preferred.
Salary Range: $40.39 - $55.53
