Darshan Patel Email & Phone Number

Supported a range of Analytical tests including Cell count and Immunophenotyping using BD FACSLyric, qPCR, Potency assays and Sterility of In Process, Stability and Release Drug Product samples.Ensured laboratory housekeeping and maintenance of laboratory to ensure MHRA and FDA inspection ready state.Operated and maintained analytical instruments in accordance to governing SOPs and in line with GMP.Participated in execution of qualification scripts (IOPQ).Initiated and owned of deviations, laboratory investigations, change controls and CAPA as required. Conducted root cause analysis using appropriate tools and performed impact analysis.Lead internal QC investigations forming part of deviation and laboratory investigation.Archived GMP records and completed GMP documentation in accordance with ALCOA/data integrity requirements.Designed and managed GMP documentation e.g. logbooks, forms and worksheets.Prepared high quality SOPs and CoAs.Participated in Tech Transfer and Validation of Analytical methods.

Supported the development of analytical methods to assist both process development and manufacturing of cell and gene therapy products.Performed various Flow Cytometry methods such as immunophenotyping of Claudin-3 transduced T cells to determine transduction efficiency and Cell Count and Viability using MACSQuant analyser.Performed quantification of Residual Double Stranded DNA in Lentiviral Vector (LVV) preparations.Quantifyied physical titre (total number of particles) of in-process steps and purified LVV, by the titration of HIV-1 p24 using ELLA automated microfluidic GNRs (Glass Nano Reactors) based cartridge system.Carried out sample content transfer in a GMP QC laboratory.Trained in routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.Reviewed the compilation of results performed by other analysts.Supported training of colleagues in QC and Product Development.Supported laboratory and equipment maintenance.

United Kingdom

Performed QC testing of raw materials, in-process and drug product samples whilst maintaining cGMP and GDP.Testing involved but not limited to viral expression and potency assays to measure infectious and phycial viral titre, such as Plaque, GALV GP protein expressed in HT1080 cells.Assay Cell Proliferation by quantifying ATP generation using CellTiter-Glo.Sandwich ELISAs for quantitative measurement of viral antigen (HSV) and Host Cell Proteins (HCP).Performed Cell Culture of adherent cell lines on a regular basis by revival and passaging at set intervals.Reviewed testing data and records of other operators and data verification of reports.Performed QC sample and material receipt, maintain inventory and ordering supplies.Carried out routine equipment maintenance and troubleshooting as required.Trained other analysts within department within scope of knowledge where applicable.Wrote and revised SOPs, protocols and updated as required.Participated in QC method transfer, qualification and stability activities.Involved with various QC GMP documentations such as raising and writing Change Controls, Deviations, Out Of Specifications (OOS) and Lab Investigations (LIs).Assisted with internal agency audits/inspections.

United Kingdom

Adhered to SOPs to perform GMP testing. Performed ELISAs, SDS-PAGE and RNA Extraction.Carried out routine tasts to maintain laboratory as directed by line manager.Attended training as and when required to attain new skills.Ordered consumables, reagents and equipment as required.

United Kingdom

Developed and validated Analytical testing methods (whole cell ELISAs, RNA Extraction and SDS-PAGE) for GMP veterinary vaccines for both in-house and third-party projects.Worked on developing Analytical assays for Photobacterium, Nodavirus and VibrioWrote development protocols, reports and SOPs for methods.Performed co-validation work with Tech Transfer staff to ensure validation in both originating and receiving laboratories.

Essex, England, United Kingdom

Dealt with customer queries and attended to their needs such as dealing with long queues and helping the elderly with shopping.Replenished stock and discarded out of date products.Remove and record the amount of cash in register at end of shift.

Master'S Degree, Clinical Biochemistry

Dissertation: Development of Sandwich and Competitive ELISAs specific towards hypothalamic POMC-derived neuropeptides (alpha-MSH.

Bachelor'S Degree, Biochemistry

A Levels

3 x A-levels: Chemistry, Biology, Mathematics

Gcse'S

10 x GCSEs at A* - C including English, Mathematics and Science