Senior Manufacturing Associate I/II-Upstream

Position Summary

The Sr. Manufacturing Associate I/II – Upstream is responsible for the execution of production activities for early and late-phase Cell Culture programs within a GMP environment. 

The Sr. Manufacturing Associate I/II – Upstream must follow the instructions depicted in SR’s, EPR’s, BR’s, 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). Identify possible process and record improvements and communicate this to the appropriate personnel.

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 cell culture fundamentals in cell culture media preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest setup and operations, and aseptic technique; as well as in cell culture 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 Upstream manufacturing. The Sr. Manufacturing Associate I/II – Upstream will promote and enforce precise and compliant operations.

The Sr. Manufacturing Associate I/II will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Sr. Manufacturing Associate I/II will review the executed production records (SR’s, ERP, and BR’s) to ensure a comprehensive and accurate set of actions have occurred. It is management’s expectation that any deviations/events are documented and escalated to the Management and Quality system according to KBI internal notification processes.

Position Responsibilities

• Manufacture cell culture 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.
• Provide direction/guidance to Manufacturing Associate I and Manufacturing Associate II, Senior Manufacturing Associate I and Senior Manufacturing Associate II. Help supervisor to distribute the workload and ensure others understand the requirements of their tasks.

Position Requirements

• Sr. Manufacturing Associate I- Bachelor’s degree in a related scientific or engineering discipline with 4-6 years’ experience in related GMP manufacturing operations; or high school diploma with 7-10 years’ experience in related GMP manufacturing operations.
• Sr. Manufacturing Associate II- Bachelor’s degree in a related scientific or engineering discipline and 5 years’ experience in related GMP manufacturing operations; or high school diploma with 10 years’ experience in related GMP manufacturing operations.
• Demonstrated knowledge of cell culture or fermentation unit operation 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

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.