Manufacturing Associate I/II-Upstream-3

KBI Biopharma•Durham, NC

24d

About The Position

The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream 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). As needed, the Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment. The Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest) activities. The Manufacturing Associate will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment). Additionally, the manufacturing associate will know general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Following task execution, the Manufacturing Associate will review the executed production records and logbooks to ensure GxP compliance. The Manufacturing Associate will execute daily tasks and maintain strict adherence to manufacturing records, SOPs, and GMP guidelines. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. Staff will work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant. A proven Manufacturing Associate will demonstrate the following qualities: learning agility, orientation toward action, results-driven, team player, strong attention to detail, and superior integrity and accountability. Preferred 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. Other Qualities Basic knowledge of upstream (cell culture or fermentation). Experience in single-use platform technology is preferred. Excellent written and verbal communication skills are required. Energetic, motivated, and dynamic individual. Must be organized and able to focus in a fast-paced, multi-tasked environment, and maintain operational efficiency and positive demeanor. 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.

Requirements

learning agility
orientation toward action
results-driven
team player
strong attention to detail
superior integrity and accountability
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.
Excellent written and verbal communication skills are required.
Energetic, motivated, and dynamic individual.
Must be organized and able to focus in a fast-paced, multi-tasked environment, and maintain operational efficiency and positive demeanor.

Nice To Haves

Basic knowledge of upstream (cell culture or fermentation).
Experience in single-use platform technology is preferred.

Responsibilities

performing upstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products
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)
author standard operating procedures (SOPs) or Master Batch Records (MBRs)
write corrective and preventive actions (CAPAs)
specify, commission, and qualify new equipment
responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest) activities
review the executed production records and logbooks to ensure GxP compliance
execute daily tasks and maintain strict adherence to manufacturing records, SOPs, and GMP guidelines
maintain a sense of ownership of the production processes, the manufacturing environment, and the facility
work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant