Downstream Supervisor/Sr. Supervisor

Job summary

The Supervisor/Sr. Supervisor, Manufacturing, Floor Operations (Supervisor) leads a team of manufacturing associates to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Supervisor will plan, assign, and monitor 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 will also lead teams on projects to author standard operating procedures (SOPs) or Master Batch Records (MBRs); implement corrective and preventive actions (CAPAs); and help specify, commission, and qualify new facilities and/or equipment.

A proven and qualified Supervisor will use knowledge and experience in upstream processing (seed expansion, bioreactor operations, cell culture harvest), downstream processing (purification and bulk filling) to teach others, troubleshoot, and continuously improve daily operations, and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. The Supervisor will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers).

Additionally, the Manufacturing Support supervisor manages the staff who clean the GMP facilities. 

The Supervisor will review manufacturing procedures and train manufacturing personnel to ensure that 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 executed production batch records and production orders to ensure a comprehensive and accurate set of actions have occurred. It is management’s expectation that all deviations/events are documented and escalated according to KBI internal notification processes.

The Sr. Supervisor will use leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, troubleshoot issues, and track/trend metrics.

Job Responsibilities

• Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP 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. 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 maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.

• 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.

Minimum Requirements

• Supervisor: 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. 

• Sr. Supervisor: Bachelor’s degree in a related scientific or engineering discipline and 8 years’ experience in related cGMP manufacturing operations; or high school degree and 12 years’ experience, or equivalent, and 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.

• For Supervisor, prior experience in a leadership/supervisory role 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.

The job requires working 12 hour shifts which may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.

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.