Manufacturing Supervisor (Nights)

About the role

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 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, such as current Good Manufacturing Practice (cGMP). 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), and support continuous improvement initiatives involving safety, quality, delivery, engagement, and cost in accordance with 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 maintain a working knowledge of bioprocessing equipment, including filters, filter integrity testers, balances, pumps, analytical instruments, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers).

Responsibilities

• Support daily production tasks to ensure schedule adherence while maintaining cGMP compliance.
• 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 staff maintain a high level of compliance with procedures and quality expectations.
• Oversee maintenance, cleaning, and timely submission of work orders for facility and equipment maintenance and repair.
• Author, train, and 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.

Time allocation: 30% batch documentation and logbook review, 10% process improvement and troubleshooting, 60% other duties as listed.

Requirements

• Bachelor’s degree in a related scientific or engineering discipline and 4 years’ experience in 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 biopharmaceutical production 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.
• Organized, able to focus in a fast-paced, multi-tasked environment, and maintain operational efficiency and a positive demeanor.
• Fluent in reading and writing English; ability to interpret documents such as safety rules, operating instructions, procedure manuals, batch records, and production records.
• Ability to solve practical problems with limited standardization and interpret instructions in written, oral, diagram, or schedule form.
• Basic math skills: addition, subtraction, multiplication, division, rate, ratio, percentage, and graph interpretation.

Skills

• Proficient in MS Office, ERP, EDMS, production equipment software, and other relevant systems.
• Experience with upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.

Schedule

12-hour night shifts on a 2-2-3 schedule, including weekends and holidays.

Working Conditions

• Work within a cGMP manufacturing biotechnology facility, including clean room operations requiring clean room attire and good personal hygiene.
• Exposure to mechanical, chemical, and electrical hazards, as well as tripping and falling risks.
• Moderate to high noise levels in the environment.

Physical Demands

• Standing: 50% of the time during production activities.
• Walking: 25% of the time throughout the facility.
• Sitting: 25% of the time for training, document review, and computer work.
• Lifting/Carrying: Up to 50 lbs (20 kg bags of WFI, Buffer, and Media).
• Pushing/Pulling: Up to 450 lbs (200 kg drums of WFI, Buffer, and Media).
• Climbing/Balancing: Operations on ladders or step stools.
• Stooping/Kneeling/Crouching: Reaching underneath production equipment for bioprocess container installation and inspection.
• Reaching/Handling: Reaching within, over, and underneath production equipment.
• Speaking/Hearing: Fluent English; communication over radios, cell phones, and in noisy production environments.
• Seeing: Ability to read manufacturing procedures and execute production activities.