Job Summary

The incumbent will oversee tech transfer activities for Upstream or Downstream Manufacturing and serve as the technical leader for the department. The Specialists’ Manager will oversee the Upstream or Downstream Manufacturing specialist team to ensure that Manufacturing tech transfer responsibilities are met to ensure ‘On-Time” and “Right the First time’ execution of production activities. The individual will oversee manufacturing record generation, equipment enrollment, operation, and maintenance, manufacturing projects and studies, and drive operational excellence initiatives for the department. The Specialists’ Manager will oversee Manufacturing Specialists and will report to the Director of Manufacturing Technical Operations. The individual will be responsible for managing mid-term and long-term manufacturing readiness planning and be the primary point of contact for daily issue escalation with respect to tech transfer and readiness tasks. The individual will ensure their team maintains strict accordance with SOPs and Good Manufacturing Practices. The individual will also be responsible for ensuring their staff work cross-functionally to ensure operations are both reliable and successful. This requires a drive for continuous improvement and simplicity and looking for opportunities to ensure equipment operation is reliable. This proven and qualified candidate will use their past experiences, depth and knowledge of fundamentals in media/buffer preparation, seed expansion, bioreactor operations, cell culture harvest operations, chromatography, ultrafiltration/nanofiltration and drug substance filling operations to teach, troubleshoot and continuously improve the production operations of Manufacturing. The ideal candidate will be both technically sound as well as an experienced team motivator and coach. The Specialists’ Manager will use their leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment and troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed.

Job Responsibilities

• Oversee manufacturing tech transfer activities including: Manufacturing record generation, MRP BOM and work order generation, and enrollment of materials and equipment
• Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed
• Supervise, coach, mentor and train team members to maintain educated, qualified and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations.
• Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed
• Ensure equipment and Manufacturing facilities remain in working order by overseeing manufacturing specialists and ensuring vendor repairs as needed, maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.

Job Requirements

Bachelor’s degree in a related scientific or engineering discipline and 10+ years’ experience in related GMP manufacturing operations; 6+ years prior leadership/supervisory experience.

• Demonstrated knowledge of cell culture, fermentation, or purification unit operation is preferred.
• Experience in single-use platform technology is preferred.
• Excellent written and verbal communication skills are required.
• Energetic, motivated and dynamic individual.
• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

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.