Manufacturing Associate I/II

KBI Biopharma; Boulder (CO); On-site; USD 3,642,000 - 5,756,000; Full time

Job summary

KBI Biopharma in Boulder, Colorado, is seeking a Manufacturing Associate I/II to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The role requires following approved procedures to ensure Right First Time work under GMP/GLP, with strong documentation practices.

You will work on a 2-2-3 schedule from 6:00 AM to 6:30 PM, in a cleanroom environment, applying aseptic controls, maintaining records, and ensuring cGMP adherence

Qualifications

• 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.
• 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.
• 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).

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.

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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.