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durham, nc
Posted
6 days ago

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durham, nc

Job Description

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The Sr. Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest), downstream unit operations (chromatography, tangential flow filtration, viral inactivation, and bulk filling) and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. The Sr. Manufacturing Associate will have past experience and a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). The Sr. Manufacturing Associate will use past experiences and knowledge to teach, troubleshoot and continuously improve the daily operations of upstream or downstream manufacturing. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. The Sr. Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP with minimal supervision and effectively communicate with the manufacturing supervisor and support groups. Staff will work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant. The Sr. Manufacturing Associate will also be expected to review the manufacturing schedule, executed manufacturing documentation, and ERP orders to ensure compliant operations and schedule adherence. Staff will effectively communicate questions, concerns, or deviations to management and the quality system according to KBI internal notification processes. 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.

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