KBI: US - Downstream Senior Manufacturing Associate II (Night Shift)

About the role

Nightshift: 7PM–7AM, 2‑2‑3 rotating schedule. The Senior Manufacturing Associate II – Nights is responsible for performing downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. Work follows written, approved procedures and forms to ensure “Right First Time” (RFT) execution under Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP). The role may involve authoring standard operating procedures (SOPs) or Master Batch Records (MBRs), writing corrective and preventive actions (CAPAs), and specifying, commissioning, and qualifying new equipment. Responsibilities cover downstream unit operations (chromatography, tangential flow filtration, viral inactivation, bulk filling) and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, autoclave). The associate must have working knowledge of downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters) and/or manufacturing support equipment (mixing vessels, parts washers, autoclaves), as well as general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). The position requires using experience to teach, troubleshoot, and continuously improve daily operations, maintaining ownership of production processes, the manufacturing environment, and the facility. Daily tasks are executed in strict accordance with manufacturing records, SOPs, and GMP with minimal supervision, with effective communication to the manufacturing supervisor and support groups. Cross‑functional collaboration with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other departments ensures startup and ongoing operations are successful, reliable, and compliant. The associate reviews the manufacturing schedule, executed documentation, and ERP orders to ensure compliant operations and schedule adherence, and communicates questions, concerns, or deviations to management and the quality system per KBI internal notification processes.

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 and be accountable for workplace organization (5S).
• Provide direction/guidance to Manufacturing Associates; help supervisor distribute workload and ensure others understand task requirements.

Requirements

• 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 required.
• Energetic, motivated, and dynamic individual.

Qualifications

• Language Ability: Fluent in reading and writing English; ability to read and interpret safety rules, operating and maintenance instructions, procedure manuals, batch production records; ability to write routine reports and correspondence; ability to speak effectively to groups.
• Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables where only limited standardization exists; ability to interpret instructions furnished in written, oral, diagram, or schedule form.
• Math Ability: 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.

Skills

• Computer Skills: MS Office, ERP, EDMS, production equipment software.
• Equipment Use: Downstream bioprocessing equipment, general production equipment, in‑process testing instruments, and office equipment.

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.