Lead Manufacturing Associate

KBI Biopharma•Boulder, CO

4d•Onsite

About The Position

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.

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.

Nice To Haves

Knowledge of Upstream (Cell Culture or Fermentation) or downstream (Purification and Bulk Fill) operations is preferred.

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.
Provide direction/guidance to Manufacturing Associates and Senior Manufacturing Associates.
Provide detailed status of processes and equipment to other staff members.
Fill in when the Manufacturing Supervisor is not available.