Manufacturing Supervisor, Solution Prep

Job Summary

Manufacturing Supervisor, Solution Prep leads a team of manufacturing associates to perform both upstream and downstream preparation of solutions and growth media used for processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The individual plans, assigns, and monitors daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP).

As needed, the Supervisor may also support core production operations (cell culture or purification), lead teams on projects to author standard operating procedures (SOPs) or batch and solution records; implement corrective and preventive actions (CAPAs); support continuous improvement and other initiatives involving safety, quality, delivery, engagement, & cost in accordance to KBI/JSR business objectives.

• Support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution.
• Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, 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.
• Author, train, review manufacturing procedures.
• Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed.

• 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.
• Demonstrated knowledge of mammalian cell culture (or microbial fermentation) or purification operations for production of biopharmaceuticals is preferred.
• Experience in single-use platform technology is preferred.
• 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.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.