Bishop's Stortford, England, United Kingdom
Hello, I'm an professional with demonstrated history of setting up reliable quality control methods over the last 8 years. Across multiple organizational levels to accomplish and maintain top-tier standards for biological / chemical testing. I am recognized for my ability to build and leverage collaborative efforts with team members and key stakeholders to achieve goals. My recent experience has specialised in both the Cell therapy and Viral vectors (AAV) fields. Further, I am talented in drafting and implementing quality policies and procedures. I am equipped with expertise in evaluating effectiveness of quality control procedures and providing required recommendations. I am adept at tracking quality metrics as well as monitoring compliance with for GMP and safety standards. Subject matter expert; capable of utilising effective tools and techniques, such as Flow cytometry, HPLC, CE SDS, ELISA and qPCR/ddPCR to perform tests as well as review and audit test results. I am also capable of evaluating complex situations and finding solutions by leveraging my analytical skills. Accustomed to highly regulated, fast paced environments requiring keen attention to detail and ability to manage multiple and varied tasks and prioritize workload.
• Lead development and optimisation of analytical methods for the Quality Control (QC) of novel Biomedicines (viral vectors – AAV’s & cell therapies) adhering to quality by design principles. • Interaction with industry and academic based groups to provide sound scientific solutions for analytics of cell therapy and other products. • Working closely with the QC and Development teams to ensure successful delivery of project outputs to schedule and within budget, including detailed work breakdown structures and project plans to ensure delivery to agreed outcomes. • Collaborate with Upstream and Downstream Processing teams, across Catapult sister sites for optimised delivery of cutting-edge analytics & facilitate collaboration with third party cell and gene therapy organisations for the delivery of therapies to patients.
· Contributing to both internal and external Tech Transfer activities & delivery of on-time technology transfer projects · Delivery of, on-time project goals and milestones from external CMOs through technical collaboration and direct input to the project activities · Tech transfer of analytical methods both into and out of the business. · Strong interaction with the Analytical Sciences group and the Innovation Team to enable the transfer and validation of analytical methods for use in QC. · Interaction with industry and academic based groups to provide practical analytical/science-based solutions for analytical method transfer activities associated with cell/gene therapy products.
Plan and execute quality tests and control activities (e.g. QC and release incoming goods, QC of IPC and final product, QC sample and results management) including documentation. · Monitor stock levels inclusive of forms within quality laboratory. · Write and review documentation (e.g. SOP’s, Quality Instructions, protocols) related to quality control activities. · Contribute to QRB, EM excursion reports and investigations. · Successful establishment of QC analytics for preclinical, phase I/II/III products across multiple projects
Selected for a 6 month work secondment at Lonza CH as a QC Scientist, my role Includes: • Representation of QC Mammalia in interdisciplinary project team to facilitate successful technology transfer for products phase II/III & commercial • Independent supervision of studies and projects with responsibility for their success Writing SOPs, protocols and reports • Interpretation and presentation of data • Scientific based solutions of complex problems • Leading studies and troubleshooting in the lab for a range of analytical methods (E.g. RP-HPLC, SE-HPLC, GP-HPLC, icIEF, CE SDS
• Sampling and analysis of raw materials, drug substances and drug products. • Documenting analytical data and results according to cGMP • Carrying out routine testing of raw materials and diagnostic products • Updating and maintaining documentation as required – LIMS system • Use of the following techniques; GC, Karl Fischer, FT-IR, DSC, HPLC, UV, AA and various USP and EP testing.
• Working in ISO 7 cleanroom producing a Class I continuous glucose monitoring medical device • Responsible for bioburden and air sampling tests • Implementing both production and QC processes whilst maintaining high health and safety standards • Improving and maintaining QMS systems whilst under ISO 13485 GMP compliance including writing work instructions and SOP’s • Ensuring high quality assurance standards are met at all times
• Synthesising a range of over 80 mods on a daily basis, including NHS esters and other high end products, used in services such as medical research and vaccine devlopement • Working independently to troubleshoot and correct problems whilst reporting using CAPA’s • Utilising a range of scientific tools/machines to work with whilst maintaining their upkeep • Maintaing a high throughput environment whilst under ISO 9001 & ISO 13485 controls to ensure high standards are met consistently in combination with standard SOPs