Job Description

The Manufacturing Associate I/II (Day Shift) is responsible for the execution of Downstream production activities for early and late-phase Cell Culture programs within a GMP environment. The Manufacturing Associate I/II must follow the instructions in SRs, EPRs, BRs, SOPs and forms while adhering to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time’ (RFT). The ideal candidate will be both technically sound and have a quality mindset. The candidate will use and demonstrate their past experiences and knowledge of Downstream fundamentals in aseptic technique, chromatography, viral filtration, ultrafiltration/diafiltration, and filling operations; as well as in analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolarity meters) to teach, troubleshoot and continuously improve the daily operations of manufacturing. The Manufacturing Associate I/II will promote and enforce precise and compliant operations. The Manufacturing Associate I/II will maintain a sense of ownership of the production processes, manufacturing environment and facility.

Job 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 procedures (i.e. SRs, EPRs and BRs) 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. 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

• For Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline with 0-2 years’ experience in related GMP manufacturing operations; or high school diploma with 3-5 years’ experience, or equivalent.

• For Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 2-5 years’ experience in related GMP manufacturing operations; or high school diploma with 4-6 years’ experience, or equivalent.

• Basic knowledge of downstream (purification, filtration, bulk filling) is preferred.

• Experience in single-use platform technology is preferred.

• Fluent in English language both reading and writing, able to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.

• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

The job requires working 12-hour shifts on a 2-2-3 rotation. The job requires working within a cGMP manufacturing clean room with appropriate clean room attire and PPE and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which may include mechanical hazards, chemical hazards, electric hazards, and tripping and falling hazards. Following all safety procedures and PPE requirements is mandatory. The noise level in the environment can be moderate to high. Standing for long periods of time, lifting, pushing, pulling, and the use of a ladder may be required.

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.