Senior Manufacturing Associate I/II

3 weeks ago

Durham, United States KBI Biopharma Full time

Position Summary

The Senior Manufacturing Associate I/II is responsible for performing upstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Senior Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and/or Good Laboratory Practices (GLP). As needed, the Senior Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write Corrective and Preventive Actions (CAPAs); and specify, commission, and qualify new equipment.

The Senior Manufacturing Associate will responsible for upstream unit operations (see expansion, bioreactor operations, cell culture harvest). The Senior Manfuacturing Associate will have past experience and working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment). 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. The Senior Manufacturing Associate will use past experiences and knowledge to teach, troubleshoot, and continuously improve the daily operations of upstream manufacturing. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility.

The Senior 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 closely 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 Senior Manufacturing Associate will also be expected to review the manufacturing schedule, execute 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.

Position 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 records and logbooks 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 Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities Participate and be accountable for workplace organization (5S) Provide direction/guidance to Manufacturing Associates. Help supervisor to distribute the workload and ensure others understand the requirements of their tasks.

Position Requirements

Senior 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 Senior Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 5+ years’ experience in related GMP manufacturing operations; or high school degree with 10+ years’ experience in related GMP manufacturing operations Knowledge of upstream unite operations preferred Experience in single-use technology preferred Excellent written and verbal communication skills are required

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