Setting standards, monitoring and guiding overall performance of the teams responsible for GMP facilities and technical equipment, environmental monitoring, procurement and material management activities. Ensuring GTVF CDMO has resources to deliver end-to-end viral vector production for both academic and commercial clients, with a focus on early stage clinical activity.

Health and safety risk assessments/COSHH, develop URS and oversee validation lifecycle activities (DQ, FAT/SAT, IOPQ and ongoing PPM), agree and maintain SLAs, deviation RA and change control oversight for GMP facilities and equipment, design build and qualification of new cleanroom laboratories. FMS/BMS/HVAC SME.

Provide quality support to all Cell and Gene Therapy GMP manufacturing activities at King’s College (CGT-K). Responsible for initial quality review of documentation including Operator Validations, Equipment service/Calibration/Maintenance reports and daily logs. Draft quality system documentation including but not limited to Standard Operating Procedures and Batch Manufacturing Records. Assist the QA and production Team in the investigation and closeout of deviations, non-conformances, change controls and quality exceptions as required. Participate in the conduct of internal and external audits. Solely responsible for the overall management of departmental equipment servicing and calibration scheduling and documentation. Populate, validate and implement new InvyTrack stock management software system. Develop a good working knowledge of HTA and MHRA/EU regulations in relation to GMP.

• Daily tasks involved a range of clinical scientific procedures: blood cell culture and harvesting,producing slides for karyotyping and FISH analysis, giemsa banding, microscopy etc• Preparation of reagents, chemical disposal, laboratory stock maintenance, ensuring accurate records in accordance with good laboratory practice• Communicating with patients and their respective consultants to resolve issues and queries• Carefully reviewing the accuracy of final diagnostic patient reports before they are released• Training new members of staff in accordance with TDL laboratory SOPs• Utilising good knowledge of WinPath LIMS software and Microsoft Office Suite for managementof patient data • Active participant in our bi-monthly academic journal club, where the latest trends in medicalgenetics are presented and discussed• Maintaining professional development, training in Cytogenetic Analysis team (analysingchromosomes for genetic abnormalities)

Assisted the prenatal laboratory team in all scientific and administrative duties, primarily workingwith amniotic fluid, chorionic villi and products of conception.