WuXi Vaccines, a subsidiary of WuXi Biologics, focuses on human vaccine discovery, development and manufacture.
An exciting new addition to the WuXi Biologics family, WuXi Vaccines will bring to the global vaccine industry the world-class integrated platforms and CDMO business model on which WuXi Biologics reputation is based.
In development is an integrated vaccine manufacturing facility with 240 million US Dollar investment, including drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC), dedicated to manufacturing our partner's vaccine products for the global market.
Job Summary: Perform cell culture/banking, cell based potency assay, qPCR assay and lab maintenance duties in accordance with relevant SOPs, analytical method protocols (AMPs), and cGMP regulations in the Dundalk, Ireland QC Vaccines lab Responsibilities: Execute cell-based Potency testing and Identification testing to the highest standard in compliance with internal procedural requirements Serve as a technical contributor to develop, qualify, and/or validate/transfer cell-based Potency methods and Identification assay to support QC release and stability testing in a cGMP environment Manage reagents and consumables inventory Maintain a clean, safe and organized laboratory environment according to 5S and EHS guidelines and perform relevant training Participate in quality system investigation/documentation preparation, Execute action items for quality system assigned by supervisor and Provide technical guidance to junior analysts to support deviations, atypical/OOS investigations, change controls, and CAPAs.
Guide method trouble-shooting and implement improvements to existing methods as needed Draft and revise of analytical methods, testing protocols and reports, lab management documents and other technical documents Perform method development, optimization, and validation of potency assay Document/review completed lab work and results promptly, clearly, and accurately Prepare presentations and written reports of experimental results and analyses and effectively communicate with internal stakeholders and client Work collaboratively with clients for method validation/transfer/data trending and routine testing to meet project cGMP release/stability testing needs Work with supervisors and other team members to review and monitor method performance Train juniors for maintaining compliance and high quality standards Ability to work in a team environment and independently as required Ability to contribute regulatory inspections from FDA, EMA, HPRA, etc.
and cGMP audits from clients, as well as internal Quality Assurance Education & Experience: Degree in Immunology, Virology, Chemistry, Biochemistry, Molecular Biology, Analytical or related discipline Experience with cell-based potency assay and/or PCR (at least 2 years) in an GMP environment is required Experience with biosafety containment levels CL-2 is preferred Experienced with LIMS/trackwise is preferred Demonstrates good understanding of analytical and QC operations in the biopharmaceutical/vaccine industry Working knowledge and understanding of current regulations and industry trends for vaccines product development, manufacture and testing, including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required