Lead Manufacturing Associate

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 and 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 records, reviewing batch records real-time and escalating 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 and guidance to Manufacturing Associates and Senior Manufacturing Associates and fill in when the Manufacturing Supervisor is not available.

• 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.
• Continuous improvement, Right-First-Time mentality.
• Knowledge of Upstream (Cell Culture or Fermentation) or downstream (Purification and Bulk Fill) operations is preferred.

$40.39 - $55.53 K

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.