Manufacturing Supervisor

KBI Biopharma•Durham, NC

8d•Onsite

About The Position

The 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 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 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. A proven and qualified supervisor will use knowledge and experience to execute production operations, coach staff, troubleshoot, and continuously improve daily operations and/or manufacturing support operations. The Supervisor will have a working knowledge of bioprocessing equipment. including but not limited to, filters, filter integrity testers, balances, pumps, analytical instruments, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). The Supervisor will review manufacturing procedures and instruct 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 documents to ensure accuracy and completeness. It is management’s expectation that supervisors uphold the company’s core competencies and departures from specifications and/or policies are reported according to KBI internal notification processes. 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 with 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.

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.
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.
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 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.

Nice To Haves

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.

Responsibilities

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).
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.
Execute production operations, coach staff, troubleshoot, and continuously improve daily operations and/or manufacturing support operations.
Review manufacturing procedures and instruct manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly.
Maintain a sense of ownership of the production processes, manufacturing environment and facility.
Review executed production documents to ensure accuracy and completeness.
Uphold the company’s core competencies and report departures from specifications and/or policies according to KBI internal notification processes.
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 with 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.