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

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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.