KBI: US - Manufacturing Associate II

This position follows a 2-2-3 shift schedule on the Day Shift (6am-6pm).

About the Role

The Manufacturing Associate I/II is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The role requires adherence to written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP).

As needed, the Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment.

The role involves upstream unit operations (seed expansion, bioreactor operations, cell culture harvest), downstream unit operations (chromatography, tangential flow filtration, viral inactivation, and bulk filling), and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave).

A successful Manufacturing Associate will demonstrate learning agility, orientation toward action, results-driven focus, teamwork, strong attention to detail, and superior integrity and accountability.

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 Good Documentation Practices (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 (e.g., SR, EPR, and BR).
• Demonstrate, apply, and ensure understanding of current Good Manufacturing Practice (cGMP) and how it applies to specific tasks and responsibilities.
• Participate in and be accountable for workplace organization (5S).
• Work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure successful, reliable, and compliant manufacturing operations.

Requirements

• Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline and 0-2 years’ experience in related cGMP manufacturing operations; or high school degree and 3-5 years’ experience, or equivalent.
• Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline and 2-5 years’ experience in related cGMP manufacturing operations; or high school degree and 4-6 years’ experience, or equivalent.
• Basic knowledge of upstream (cell culture or fermentation), downstream (purification and bulk filling), or manufacturing support unit operations is preferred.
• Experience in single-use platform technology is preferred.
• Excellent written and verbal communication skills.
• Energetic, motivated, and dynamic individual with the ability to stay organized and focused in a fast-paced, multi-tasked environment while maintaining operational efficiency and a positive demeanor.

Skills

• Equipment Knowledge: 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). 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).
• Language Ability: Fluent in reading and writing English. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, and 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 concrete variables in situations with limited standardization. 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.
• Computer Skills: Proficiency in MS Office, ERP, EDMS, production equipment software, and other relevant software.

Physical Demands

• Standing and sitting for long periods of time 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.
• Regular use of upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.

Working Conditions

• 12-hour shifts, which may include working overnight.
• Work within a cGMP manufacturing biotechnology facility, including cleanroom operations that require donning cleanroom attire and maintaining good personal hygiene.
• Exposure to mechanical hazards, chemical hazards, electrical hazards, and tripping/falling hazards.
• Moderate to high noise levels in the environment.

Schedule

2-2-3 shift schedule on the Day Shift (6am-6pm).