Supervisor, Manufacturing Support

KBI Biopharma Inc.; Durham (NC); On-site; USD 100,000 - 125,000; Full time

Job description

Supervisor, Manufacturing Support

Position 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.

Position 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.

Position 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.

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.
• 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 fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
• Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.
• MS Office, ERP, EDMS, production equipment software, other.
• Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.