Supervisor, Manufacturing - Night Shift

Please Note: This position is a night shift position that operates on a 2-2-3 schedule and is eligible for a shift differential. JOB SUMMARY: * The incumbent will lead manufacturing planning to ensure 'Right the First time' execution of early and late-phase Cell Culture programs safeguarding work environments and enforcing cGMP compliant operations. Production scope Upstream or Downstream processing. * Supervisors will assign and supervise daily tasks of team members and maintain strict accordance with production batch records, SOPs and Good Manufacturing Practices. * This proven and qualified candidate will use their past experiences, depth and knowledge of cell culture fundamentals in media preparation, seed expansion, bioreactor operations, cell culture harvest operations, chromatography, ultrafiltration, and drug substance filling operations to teach, troubleshoot and continuously improve the daily operations of Manufacturing. * The ideal candidate will be both technically sound as well as an experienced team motivator and coach. * Demonstrated knowledge of media preparation, shake flask operations, reactor setup and operation, aseptic technique, cell culture media preparation, chromatography, ultrafiltration, and drug substance filling operations, analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolarity meters) is expected as the supervisor will teach, promote and enforce precise and compliant operations. * The supervisor will review and understand manufacturing procedures and apply their fundamental knowledge combined with production batch records to train manufacturing personnel ensuring manufacturing operations are conducted accurately, safely and compliantly. * The supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the supervisor will review the executed production batch records, and ERP orders to ensure a comprehensive and accurate set of actions have occurred. It is management's expectation that any deviations/events are documented and escalated to the Management and Quality system according to KBI internal notification processes. JOB RESPONSIBILITIES: * Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and GMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology. * Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks. * 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. * Ensure equipment and manufacturing facilities remain in working order by overseeing production technician maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. * Author, train, review manufacturing procedures. MINIMUM REQUIREMENTS * Bachelor's degree in a related scientific or engineering discipline and 4-8 years' experience in related GMP manufacturing operations; or 10-15 years' experience with a high school degree, or equivalent. * Demonstrated knowledge of cell culture, fermentation or purification unit operation is preferred. Experience in single-use platform technology is preferred. Prior experience in a lead/leadership role 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. Salary Range: $83,530.00 - $114,854.30 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. 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.

Created: 2024-10-22