The Manufacturing Associate I/II will perform Upstream or Downstream production activities for early and late-phase Cell Culture programs in a GMP environment. Responsibilities include executing tasks per SOPs, batch records, and GMP/GDP/GLP standards, ensuring compliance and accuracy. The role involves various unit operations such as media/buffer preparation, bioreactor operations, aseptic techniques, chromatography, ultrafiltration, and drug substance filling. Candidates must maintain process ownership, facility upkeep, and thorough documentation review to ensure compliance.

The ideal candidate should have a basic understanding of cell culture, fermentation, or purification unit operations, with preference given to those experienced in single-use platform technology. Strong written and verbal communication skills are essential. The role requires an energetic, motivated, and dynamic individual who is highly organized and capable of maintaining efficiency and a positive demeanor in a fast-paced, multitasking environment

Primary Responsibilities:

• Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations.
• Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures.
• Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution.
• Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR, BR).
• Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities.
• Maintain and uphold 5S standards in the manufacturing environment.
• Operate and perform maintenance on equipment per applicable Standard Operating Procedures

Minimum Requirements:

Manufacturing Associate 1:

• Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience; OR high school diploma with 3-5 years of related GMP manufacturing experience.

Manufacturing Associate II

• Bachelor's degree in a related scientific or engineering discipline with 2-5 years of GMP manufacturing experience; OR high school diploma with 4-6 years of related GMP manufacturing experience.

. Primary Responsibilities:

• Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations.
• Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures.
• Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution.
• Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR, BR).
• Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities.
• Maintain and uphold 5S standards in the manufacturing environment.
• Operate and perform maintenance on equipment per applicable Standard Operating Procedures

Minimum Requirements:

Manufacturing Associate 1:

• Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience; OR high school diploma with 3-5 years of related GMP manufacturing experience.

Manufacturing Associate II

• Bachelor's degree in a related scientific or engineering discipline with 2-5 years of GMP manufacturing experience; OR high school diploma with 4-6 years of related GMP manufacturing experience.

• Basic knowledge of cell culture, fermentation or purification unit operations is preferred. 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 face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
• Language Ability: Fluent in English language both reading and writing. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees of organization.
• 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.
• 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 bioreactors.
• Computer Skills :
  MS Office, ERP, EDMS, production equipment software, other
• Equipment Use Examples include Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids, Filling systems, Peristaltic Pumps and Other Single Use pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, other lab, production, and office equipment.
• WORKING CONDITIONS: Are there particular working conditions associated with this position that should be noted (i.e., working environment, hours of work, travel, workspace, etc.) The job requires working 12-hour shifts which may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high. 2*2*3 working schedule for manufacturing.

Essential Physical Functions Staff will stand throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks. Staff will walk throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks. Staff will perform activities such as training, document review, and other computer work, as required. Staff will lift and carry 20kg bags of WFI, Buffer and Media within facility, as needed. Staff will push 200kg drums of WFI, Buffer, and Media throughout facility, as needed. Staff must perform some operations on ladders or step stools. Staff must perform some operations on ladders or step stools. Staff must be able to reach underneath production equipment for bioprocess container installation and inspection. Staff must be able to reach underneath production equipment for bioprocess container installation and inspection. Staff must be able to reach underneath production equipment for bioprocess container installation and inspection. Staff must be able to reach underneath, over, and within production equipment for bioprocess container installation, inspection and use. Staff must be fluent in English language. Staff must be able to speak with other staff over radios, cell phones, and within production locations over machine noise. Staff will read production instructions to others and appropriately understand instructions. Staff must be fluent in English language. Staff must be able to hear other staff over radios, cell phones, and within production locations over machine noise. Staff will listen to other staff during reading of production instructions and appropriately understand instructions. Staff must be able to read manufacturing procedures and execute production activities.

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.