• Job Description

  Req#: R00007300

  Position Summary

  This position is on 2-2-3 shifts, 7a-7p.

  The 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.

  Position Requirements

  • Manufacturing Associate I: High school diploma with 1-2 years’ of relevant experience.

  • Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 0-2 years’ relevant experience; or high school diploma with 2-4 years’ relevant experience.

  • 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.

  • Extremely high attention to detail

  Preferred Requirements

  • Basic knowledge of cell culture or fermentation unit operation is preferred. Experience in single-use platform technology is preferred.

  • Biowork certification with a High School Diploma.

  • Experience in CDMO.

  • Language Ability

  Physical Demands:

  Standing and sitting for long periods of time may be required at times. Lifting, pushing, and pulling may be required for stocking and movement of equipment. The use of ladder may be required when setting up mixing bags in Single Use Mixers.

  Computer Skills:

  MS Office, ERP, EDMS, production equipment software, other.

  Equipment Use:

  Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.

  Language Ability:

  Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch production records. Ability to write routine reports and correspondence. Ability to speak effectively to groups.

  Reasoning Ability:

  Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

  Math Ability:

  Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.

  KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

  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.

• About the company

  KBI Biopharma Inc. is a global Contract development and manufacturing organization (CDMO / CMO) offering Cell Line Development, Process Analytical & Formulation Development, Clinical & Commercial Manufacturing, Characterization & Cell Therapy services,...

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