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Manufacturing Operations Supervisor

2 months ago

Durham, North Carolina, United States KBI Biopharma Full time
Job Summary

The Supervisor, Manufacturing Support, is a key member of the KBI Biopharma team responsible for leading a team of manufacturing associates in the production of biopharmaceutical products. This role requires a strong understanding of upstream and downstream processing, as well as a focus on ensuring compliance with safety and quality regulations.

Key Responsibilities
  • Plan, schedule, and support daily production tasks to ensure schedule adherence and maintain a successful and compliant execution.
  • Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS, and Microbiology.
  • Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders.
  • Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees.
  • Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.
Requirements
  • Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations; or high school degree and 10 years' experience, or equivalent.
  • 2+ years prior leadership/supervisory experience.
  • Demonstrated knowledge of upstream (cell culture or microbial fermentation) or downstream unit operations for production of biopharmaceuticals is preferred.
  • Experience in single-use platform technology is preferred.
Preferred Qualifications
  • Knowledge of quality systems and regulatory expectations is preferred.
  • Excellent written and verbal communication skills are required.
  • Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.