JOB SUMMARY
*Nightshift: 7PM-7AM, 2-2-3 rotating schedule
The Senior Manufacturing Associate II - Nights (Sr. Manufacturing Associate) is responsible for performing downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Sr. Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP). As needed, the Sr. 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 Sr. Manufacturing Associate will be responsible for 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 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.
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 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 (i.e. SR, EPR and BR).
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.
MINIMUM REQUIREMENTS
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. Basic knowledge of upstream (cell culture or fermentation) or downstream…