Manufacturing Associate I/II

KBI Biopharma•Boulder, CO

3d•$26 - $42•Onsite

About The Position

The Manufacturing Associate I/II is responsible for performing upstream AND downstream processing of bulk intermediates and/or bulk drug substances 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).

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.

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.
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).