Position Summary

This position is on 2-2-3 shifts, 7p-7a. MFG Support Associate I/II is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment.

The Manufacturing Associate I/II - Support must follow the instructions depicted in SR's (Media / Buffer Solution Records), SOP's and forms. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including 'Right the First Time' (RFT).

The ideal candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility in activities such as dispensing raw materials, utilizing analytical scales, preparing media/buffers using various equipment like formation tanks/vessels/sum's, assembly preparation, parts washing, and autoclaving. This role focuses on providing crucial manufacturing support operations and requires a deep understanding of the fundamentals, as well as practical skills in the formulation of media's/ Buffers using stainless tanks / vessels / Sums including the use of single -use bags with mixers.

Manufacturing Support operations fundamentals, utilize knowledge and prior experiences to troubleshoot, and continuously enhance the daily manufacturing operation in the formulation of Media's/Buffers, leveraging your expertise with Stainless steel tanks / Vessels / Sums and the utilization of single-use bags with Mixers. Perform clean-in-place (CIP) procedures for tanks and auxiliary equipment, such as Transfer pumps, Crimpers, Tubing welders and sealers, pH/Conductivity meters, and Filter Integrity Testers.

Position Responsibilities

• Manufacture products per manufacturing batch records and in compliance with quality standards, company policies and current regulations. The duties required include, but are not limited to, aseptic techniques for cell culture feeding, expansion and counting.
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
• Document each task involving manufacturing procedures (i.e. SR's, EPR's and BR's) following GDP at the time of execution.
• Utilize and perform maintenance on equipment per applicable SOP.
• Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).
• Demonstrate, apply and ensure understanding of current Good Manufacturing Practices and how they apply to specific tasks and responsibilities.
• Participate and be accountable for room 5S.

Minimum Requirements

• High school diploma.
• Ability to follow written instructions.
• Excellent written and verbal communication skills.
• Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
• Energetic, motivated and dynamic individual.
• Must have high attention to detail.
• Ability to work a 12-hour schedule to include weekends, nights and Holidays.

Preferred Qualifications

• Basic knowledge of cell culture or fermentation unit operations.
• Experience in single-use platform technology.
• Biowork certification.
• Experience in CDMO.

KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.

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.