Manufacturing Associate I/II

KBI Biopharma; Boulder (CO); On-site; USD 54,000 - 76,000; Full time

Job summary

KBI Biopharma is seeking a Manufacturing Associate I/II to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances in a GMP environment. You will follow approved procedures and maintain documentation to ensure Right First Time (RFT), with adherence to GDP and GLP where applicable.

The role involves aseptic operations in a cleanroom, equipment maintenance, and strict documentation practices.

Qualifications

• Bachelor's degree in a related scientific or engineering discipline or equivalent experience.
• 0–2 years' experience in related cGMP manufacturing operations for Associate I; 2–5 years for Associate II.
• Ability to work in a cleanroom and follow GDP at the time of execution.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records and quality standards.
• Perform operations in a cleanroom with aseptic controls including gowning and cleaning.
• Document tasks in manufacturing records and logbooks.
• Maintain equipment per SOP and ensure materials are issued and accounted for.
• Understand and apply cGMP requirements to tasks and responsibilities.
• Support 5S workplace organization.

Skills

GMP knowledge

Documentation skills

6S/5S

Education

Bachelor’s degree in science or engineering

High school diploma with related experience

Tools

Cleanroom equipment

Aseptic processing procedures

Job description

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).

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.

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.

Salary Range:

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

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.