KBI: US - Senior Manufacturing Associate I

Nightshift: 7 PM–7 AM, 2-2-3 rotating schedule.

About the role

The Senior Manufacturing Associate I/II (Nights) performs upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The role requires following written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) in compliance with Good Manufacturing Practice (GMP), Good Documentation Practices, and/or Good Laboratory Practice (GLP).

The Sr. Manufacturing Associate may author standard operating procedures (SOPs) or Master Batch Records (MBRs), write corrective and preventive actions (CAPAs), and specify, commission, and qualify new equipment. Responsibilities include upstream unit operations (seed expansion, bioreactor operations, cell culture harvest), downstream unit operations (chromatography, tangential flow filtration, viral inactivation, bulk filling), and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, autoclave).

The role requires experience with 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, autoclaves). 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) is also required.

The Sr. Manufacturing Associate will teach, troubleshoot, and continuously improve daily operations, maintain ownership of production processes, and ensure strict adherence to manufacturing records, SOPs, and GMP with minimal supervision. The role involves cross-functional collaboration with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other departments to ensure compliant and reliable manufacturing operations.

Responsibilities

• Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies, and current regulations.
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing, including gowning and cleaning procedures.
• Document each task involving manufacturing records and logbooks following GDP at the time of execution.
• Utilize and perform maintenance on equipment per applicable SOP.
• Ensure all materials are issued and accounted for during the execution of a record (i.e., SR, EPR, and BR).
• Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities.
• Participate in and be accountable for workplace organization (5S).
• Provide direction and guidance to Manufacturing Associates; help supervisors distribute workload and ensure task comprehension.
• Review the manufacturing schedule, executed manufacturing documentation, and ERP orders to ensure compliant operations and schedule adherence.
• Communicate questions, concerns, or deviations to management and the quality system according to internal notification processes.

Requirements

Sr. Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline with 4–6 years’ experience in related GMP manufacturing operations; or high school degree with 7–10 years’ experience in related GMP manufacturing operations.

Sr. Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 5+ years’ experience in related GMP manufacturing operations; or high school degree with 10+ years’ experience in related GMP manufacturing operations.

• Basic knowledge of upstream (cell culture or fermentation) or downstream (purification and bulk filling) unit operations is preferred.
• Experience in single-use platform technology is preferred.
• Excellent written and verbal communication skills.
• Energetic, motivated, and dynamic individual.
• Fluent in reading and writing English; ability to read and interpret documents such as safety rules, operating instructions, procedure manuals, and batch production records.
• Ability to write routine reports and correspondence and speak effectively to groups.
• Ability to solve practical problems with limited standardization and interpret instructions in written, oral, diagram, or schedule form.
• Ability to perform basic math operations (addition, subtraction, multiplication, division), compute rates, ratios, percentages, and interpret graphs.

Physical Demands

• Standing and sitting for long periods may be required.
• Lifting, pushing, and pulling may be required for stocking and movement of equipment.
• Use of a ladder may be required when setting up bioreactors.

Skills

• Proficiency 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.

Working Conditions

• 12-hour shifts, including overnight work.
• Work within a cGMP manufacturing biotechnology facility, including cleanroom operations requiring cleanroom attire and good personal hygiene.
• Exposure to mechanical, chemical, and electrical hazards, as well as tripping and falling hazards.
• Moderate to high noise levels in the environment.