KBI: US - Senior Manufacturing Associate II

This position is on a 2-2-3 shift, Day Shift (6am-6pm).

About the role

The Manufacturing Associate I/II is responsible for performing upstream processing for biopharmaceutical products. The Manufacturing Associate must follow 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 Manufacturing Associate will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment) and general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Following task execution, the Manufacturing Associate will review executed production records and logbooks to ensure GxP compliance.

Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. They will work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant.

A proven Manufacturing Associate will demonstrate learning agility, orientation toward action, results-driven mindset, 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 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).
• Perform upstream unit operations (seed expansion, bioreactor operations, cell culture harvest).

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) unit operations is preferred.
• Experience in single-use platform technology is preferred.
• Excellent written and verbal communication skills are required.
• Energetic, motivated, and dynamic individual.

Skills

• Language Ability: Fluent in reading and writing the English language. 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 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.
• 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: MS Office, ERP, EDMS, production equipment software, and other equipment use.
• Equipment Use: Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.

Physical Demands

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

Working Conditions

• 12-hour shifts which may include working overnight.
• Work within a cGMP manufacturing biotechnology facility requiring cleanroom operations, including donning cleanroom attire and maintaining good personal hygiene.
• Regular use of equipment and materials involving mechanical, chemical, and electrical hazards, as well as tripping and falling hazards.
• Moderate to high noise levels in the environment.