KBI: US - Manufacturing Associate I​/II

Position

Schedule:

This position is for a Manufacturing Associate I/II working 6:00 AM - 6:30 PM on a 2-2-3 day shift schedule.

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 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).

• 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).

• 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.

• Manufacturing Associate I: $26.44 - $36.49 per hour
• Manufacturing Associate II: $30.29 - $41.78 per hour

• Annual bonus structure for all employees
• Medical, dental, and vision coverage
• Paid PTO and holidays
• 401K matching with 100% vesting in 60 days
• Employee recognition programs

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.