Alethiomics

Laboratory Operations Manager & Research Scientist

University of Oxford

GMP Production Manager at Clinical Biomanufacturing Facility

Wellcome Trust Centre for Human Genetics, University of Oxford

Postdoctoral Research Scientist

Research Assistant

My studies involved understanding the reasons behind persistent transgene expression after in vivo delivery of a CpG-free non-viral vector to the lung.

DPhil Student

Production Manager for the University of Oxford’s GMP facility, currently manufacturing viral vector vaccines.  The site is licensed by the MHRA for the manufacture of IMPs for Phase I/II clinical trials.  
•	Managed all aspects of aseptic production campaigns in clean rooms: maintenance, cleaning, environmental monitoring, buffer preparation, cell propagation, virus harvest, purification and final container filling.
•	Worked closely with Process Development Manager to transfer academic research-grade material and processes to achieve GMP- and large-scale compliant finished product
•	Updated and implement product specifications, SOPs and batch records.
•	Instigated audits of equipment, personnel and procedures
•	Communicated with senior management on timelines, projects and staff.
•	Contributed to updates of the Quality Management System by interacting with the Quality Team.
•	Supervised a team of two production assistants.

Production Manager at Clinical Biomanufacturing Facility

ReNeuron Ltd

•	Ensured regulatory compliance of process and materials of GMP manufactured stem cell banks
•	Project managed technical transfer of manufacturing protocols to external CMOs
•	Managed testing programmes for GMP manufactured cell banks
•	Contributed to regulatory submissions for initiation of clinical trials
•	Managed, reviewed and revised GMP/GLP test protocols and reports

Cell Manufacturing Projects Manager

As a Senior Scientist in the Human Cell Group, working as a team member on the lead project, ReN001, a stem cell line for application in stroke patients.  ReNeuron has obtained MHRA-approval for a Phase I clinical trial using ReN001.  
•	Developed and optimized protocols for release assays for clinical trials
•	Identification and audits of suitable Testing Facilities for cell testing for release of cell banks for clinical trials
•	Lead cell culturist for non-clinical toxicology studies at Charles River Laboratories
•	Troubleshooting of GMP manufacturing off-site &amp; responsible for technical transfers from R&amp;D company to GMP site

Senior Scientist

ViaCell Singapore Pte Ltd

As Lab Manager for Singapore, played a major role in establishing a cord blood research lab in Asia.  
•	Transformed an empty office shell into a fully functional research facility, producing experimental results within three months
•	Managed laboratory, including procuring equipment, reagents and supplies; recruiting candidates for research positions; transferal of cell culture technology from parent company to subsidiary
•	Acted as point of contact for vendors, agencies and collaborating companies
•	Managed vendor relationships including payment
•	Maintained monthly budget
In addition to management responsibilities, also played a key role in the research team.
•	Trained staff in proprietary processes, cell culture techniques, flow cytometry staining and analysis with a view of complete tech transfer from parent company to subsidiary
•	Responsible for experimental planning, data compilation and analysis
•	Performed experiments and assays

Lab Manager, Singapore

Research Associate in the Process Development Department.
•	Responsible for operating the Selective Amplification™ process, a patented cord blood stem cell processing system
•	Optimised the process by performing various experiments and analysing results
•	Formulated and implemented SOPs for impending clinical trials
•	Completed data audit during IND period for clinical trial approval
•	Developed shipping configuration for a final cell product
•	Acted as interdepartmental liaison for BioProcess Engineering collaborations
•	Trained research associates on thaws, cell separations, and colony assay plating

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