Manager, Manufacturing Support

Job content

Job Summary

The manufacturing support manager will oversee the management of the manufacturing support activities in support of the startup and production at a new clinical GMP biopharmaceutical manufacturing facility.

The individual will lead the manufacturing support team with the aim of achieving superior quality, safety, productivity and cost objectives.

The individual will lead the manufacturing readiness activities during the construction, commissioning, and qualification of the facility.

The manager will oversee all manufacturing support staff, with manufacturing supervisors and specialists as direct reports and will report to the VP Manufacturing Operations.

Job Responsibilities

• Plan, schedule, and support medium and long term production tasks to ensure schedule adherence to support manufacturing.
• Supervise a team dedicated to equipment support , media and buffer preparation, cleaning, autoclave activities, sampling and dispensing.
• Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology.
• Maintaining the cleanroom environments within the GMP Facility by managing and organizing the required cleanings (daily/weekly/monthly/changeover cleanings) coordinating responses with environmental excursions, building process assemblies, managing process waste from all departments and performing raw material sampling and dispensing
• Organize and coordinating room maintenance per each program (Calibrations, PM’s, Work Orders and Corrective actions) with Facility Engineering and schedule and support task with external department/venders with work orders related to GMP rooms and equipment.
• Scheduling and Coordinating of Process waste and Raw Material Sampling. Troubleshoot issues that may arise.
• Ensure timely execution and review of procedures, batch documentation, logbooks, deviations, CAPAs, change controls, and completion of ERP orders. Drive requirements to ensure rapid batch disposition.
• Hire, train and develop a highly motivated and engaged high performing team. 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. Serve as a SME during internal and external audits and inspections.
• Ensure equipment and manufacturing facilities remain in superior working order by demonstrating a clear sense of ownership, accountability, and pride by performing routine walkthroughs, setting high standards for their staff, and ensuring facility and equipment work orders are executed timely and effectively.
  
  

Job Requirements

• B.S. degree in a life sciences or engineering discipline and 9+ years’ experience in related GMP manufacturing operations or a Master’s degree and 7+ years’ experience in related GMP manufacturing operations. Level commiserate with education and experience.
• 3+ years prior leadership/supervisory experience.
• Demonstrated knowledge of cell culture or fermentation unit operations 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.
• Fluent in French with English Language capabilities both reading and writing.
• Computer Skills: MS Office, ERP, EDMS, production equipment software, other
• Equipment Use: Biosafety Cabinets, Stainless Steel Preparation Vessels, Single Use Mixers, Peristaltic Pumps and Other Single Use pumps, pH, conductivity, and Osmolality meters, other lab equipment, other production equipment, and Office Equipment.
  
  
KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.

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.