Experience

Porton Biopharma Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QC Analytical Manager

  • Jun 2022 - Present

• QC First Line Manager

  • Jan 2021 - Jul 2022

  • Ensure smooth QC operation, make GMP/operational decisions or provide solution based on evidence and risk.• Manage QC Product testing team, to support in process and batch release testing of production of fermentation, extraction, purification and formulation campaigns, routine and non-routine stability schedules.• Support non-conformance and OOS investigation as SME to aid batch disposition and compliance documentations.• Liaise with Production, Stability, QA and Development managers for work priority, to delivery results.• Support internal audit and external regulatory audits (MHRA and FDA), ensure laboratory/QMS operates to cGMP.• Ensure team members meet their objectives, KPIs and to maximise their output based on their talent.• Provide training and support to team members/junior staff for their in-job development.• Involved in method lifecycle and QMS improvements to provide operational continuality. Show less

• QC Analytical Method Specialist

  • Aug 2019 - Jan 2021

  • Coordinate with Development Group and Project Groups for method transfer, validation and troubleshoot.• Identify gaps, improvement and support method lifecycle tasks, for UV based, HP/UPLC and pharmacopeia methods.• Manage method transfer and validation projects.• Generate quality documents to support method for regulatory submission.• Technical review/report author on method related non-conformances/Quality Risk Assessments.• Support method transfer and release testing for new dossier product(s).• Complies to cGMP and regulatory guidelines (including ICH, MHRA, EMA & FDA) to all transfer/validation activities. Show less

• Senior Technologist - Product Testing (QC Analytical services - maternity cover)

  • Aug 2018 - Aug 2019

  • Laboratory Supervisor of 01/81a (QC auto-analyser Laboratory)• Schedule and troubleshoot QC testing methods including Enzyme Activity, Protein Content, Km/Kcat & KF.• GMP data verification, ensure batch release documentations are GMP compliant.• Coordinate with Fermentation Plants, Manufacture Unit and Stability Unit for testing schedule.• Liaise with QA, Manufacture unit for deviation, out of specification results and laboratory investigations.• Non-conformance, change control and risk assessment owner relevant to team activity, via eQMS.• Ensure all team members comply with COSHH, Risk Assessments and Code of Practices.• Complies with cGMP and SOPs to all testing activities and internal procedures. Show less



Intertek Melbourn

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Analytical Chemist

  • Oct 2017 - Aug 2018

  • HP/UPLC based method development, validation and stability studies, protocol writing, experiment design and execution.• Project setup, perform testing and troubleshoot client based analytical projects with pharmaceutical products, raw materials and reference standards testing.• Perform Delivered/Emitted Dose, Aerodynamic Practical Size Distributions on MDIs and DPIs.• Perform routine stability and other analysis upon client request.• Kept detailed bench work record in analytical worksheet and generate data report.• Complies with cGMP and SOPs in relation to all project activities.• Liaise with QA for deviation, out of specification and laboratory investigations. Show less

• Analytical Chemist

  • Mar 2017 - Oct 2017



Specialized Concept Store Ruislip

• Ruislip

• Part time Sales Assistant & Mechanic

  • Jun 2007 - Aug 2018

  Road, MTB and Custom build sales Custom builds and PDI General repair including brake bleed, wheel building, bar-tape. Body Geometry Fit trained technician Trade as: Action Bike Ruislip before 2010 Road, MTB and Custom build sales Custom builds and PDI General repair including brake bleed, wheel building, bar-tape. Body Geometry Fit trained technician Trade as: Action Bike Ruislip before 2010



Bristol Laboratories Ltd.

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• QC Technician (Process validation)

  • Oct 2016 - Mar 2017

  • Perform sampling of different manufacturing stages of solid dosage form pharmaceutical products. • HPLC Analysis on Identification, Assay, Dissolution, Dissolution Profile and Related substance. • Perform raw materials, intermediate products and finish products test by techniques referencing BP, Ph. Eur. and USP-NF. • Perform Instrumental analysis with UV, Dissolution-UV, Karl-fisher, and Potentiometer. • Perform physical parameter analysis on solid dosage form products, i.e. hardness, friability. • Perform test with other pharmacopeia techniques including liquid/liquid extraction, loss on drying and TLC. • Report OOS results and perform laboratories investigations. Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Student

  • Jun 2015 - Sep 2015

  Development of zein protein assay for screening ingredients harshness in oral health care product. • Plan, execute and troubleshoot experimental design in analytical method development (MSc thesis). • Integrate within New Product Research team with own research interest and target. • Plan and conduct research experiments in Microbiology and Cell Culture Laboratory. • Cell culture experience with human oral epithelial cells for viability assay and excipient screening. • Compliance with GLP and SOPs in relation to research activities. • Work presentation at team meetings and formal scientific forums. Show less