Represent QC Microbiology as a technical SME in cross-department and cross-site teams.
Design, support, and lead QC testing related to Aseptic Process Validation (APV) and Aseptic Operator Validation (AOQ).
Support design of in-process control and release testing strategy for multiple cell therapy products.
Design and execute microbiological technical studies to support current/proposed lab operations and continuous improvement.
QC Lead in drafting and supporting contamination control risk assessments for multiple cell therapy products.
Design, plan, execute, and lead EMPQ for existing facility, changes to existing facility, and new facility build-outs.
Lead the technical training function for the QC Microbiology team, including designing on-the job performance training (OJT), scheduling, execution, and continuous improvement.
Additional Skills & Qualifications:
Minimum requirements; Bachelor's Degree with 6 plus years of experience in a QC GMP lab setting.
Experience with safe lab practices and the handling of biological material.
Strong attention to detail and the ability to work cross-functionally.
Excellent communication and organizational skills.
Experience designing and executing risk assessments to support current and proposed QC testing operations. Proven experience in design and completion of method qualifications and EMPQ. Ability to participate in regulatory inspections and convey appropriate technical information clearly and concisely. Ability to exercise sound judgement and decision making to ensure compliance with regulations under aggressive timelines
Preferred requirements; Well-versed (or Subject Matter Expert) in Environmental Monitoring and Clean Utilities (purified water, compressed gases) with proven record in testing strategy and qualification of GMP classified clean rooms and utilities. Well-versed (or Subject Matter Expert) in Rapid Sterility, Endotoxin testing, and QC microbiology lab operations. 7 years of experience working in GMP QC Microbiology laboratories that support aseptic sterile GMP manufacturing.
This person would be leading the strategy and planning for utilities and/or facility qualification, designing technical studies, and leading efforts to bring in new rapid/automated technologies. We are looking for someone that enjoys being in the lab (hands on with processes and equipment). This person also will be providing technical direction to more junior staff members in the lab.
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