Senior Manufacturing Associate I/II (Days)

KBI Biopharma•Boulder, CO

7d•Onsite

About The Position

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. This position is for a Senior Manufacturing Associate I/II working 6:00 AM - 6:30 PM on a 2 - 2 - 3 Day shift schedule. The Senior Manufacturing Associate I/II performs upstream and/or downstream biopharmaceutical manufacturing processes, ensuring all work follows approved procedures, GMP/GLP requirements, and Right First Time (RFT) principles. This role requires hands-on experience with upstream, downstream, and manufacturing support equipment, as well as general bioprocessing tools. Using their technical expertise, the Senior Manufacturing Associate supports daily operations by training colleagues, troubleshooting issues, and driving continuous process improvements. The role also includes reviewing production schedules, manufacturing records, forms and ERP orders to ensure compliance and on-time execution, while promptly communicating questions, concerns, or deviations through established quality and management processes.

Requirements

Senior 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.
Senior 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.

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. SPR, BPR and Forms).
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 to distribute the workload and ensure others understand the requirements of their tasks.