Manufacturing Associate I/II (Nights)

Position Summary

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).

Schedule

6:00 PM - 6:30 AM on a 2-2-3 Night shift schedule.

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).

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.

Pay

Manufacturing Associate I: $26.44 - $36.49

Manufacturing Associate II: $30.29 - $41.78

The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range.

Benefits

• 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

About KBI Biopharma

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe.