KBI: US - Lead Manufacturing Associate; Nights

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.

• 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.

• Bachelor’s degree in a related scientific discipline with 6+ years’ experience in related GMP manufacturing operations OR a high school diploma with 12+ years’ experience in related GMP manufacturing operations.
• Ability to work a night shift is required.
• 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.
• Experience in single-use platform technology is preferred.

$47.60 – 52.88 per/hr.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.