Amer Qureshi
Didcot,Oxfordshire
Summary
Validation expert with extensive experience in Microsoft Office 365, project management software, and CRM systems including Salesforce and Zoho. Proven problem-solving abilities and strategic planning skills, complemented by proficiency in graphic design tools and data analysis software. Strong background in workflow management and quality management, with a focus on effective communication and team building. Multilingual capabilities enhance global outreach, committed to driving growth and innovation in dynamic environments.
Overview
21
21
years of professional experience
11
11
years of post-secondary education
1
1
Certification
Work history
Senior Validation Specialist
Ceva Ridgeways Biologics
Newbury
2025.03 - 2026.03
- Working with Quality Assurance and Compliance group, responsible for Validation activities around manufacturing process and critical process parameters/equipment qualification. In addition, responsible for the manufacturing of bacterial vaccines for farms and fisheries, identification of bacterial strains via molecular biology assays.
Product Validation Manager
ANGLE Europe
Guildford
2021.02 - 2024.10
- Verification and validation group lead. Established and worked on validation of instrumentation, assay systems, BioView cell imaging systems and samples to answer assay techniques. Conducting stability studies to investigate the longevity and accelerated destruction of products, including specific coated slides, specific control cells aliquots, antibodies and staining reagents. This also included the stability in transportation and desired temperature and ambient conditions. Reviewed and updated Good Documentation Practice SOPs to ensure all the documents and work generated are standardised and following the regulatory guidelines. Training staff on good documentation practice and data integrity. Attenuated and overhauled QMS for the Validation, NPD/NPI, change control and CAPA routines. Running a team of seven scientists/engineers and initiating validation programmes across the site. Responsible for team selection at the hiring stage and day-to-day management. Responsible for the release of products manufactured by CMOs including IVD equipment, antibodies and slides. Managing team yearly budget to allocate funds for upcoming and current projects. Reviewed the Research and Development reports and updated these to the quality standards. Reviewed and edited cell assays kit based on immune-histochemistry and NGS to characterise circulating tumour cells and circulating cancer DNA. Worked on Illumina NGS systems and Qiagen ddPCR platforms. Managing verification validation activities across the sight. Authored SOPs and Validation Master Plans. Supported NPD/NPI procedures and was involved in NPD gate reviews. Worked with the clinical labs to validate LIMS and various assays.
Validation Manager
Omega Diagnostics
Ely
2021.04 - 2021.01
- Responsible for the site, utilities, facilities, equipment, and method validation processes at Ely (Cambridgeshire) and Alva (Scotland) sites. Leading a team of two scientists in training in QC and validation procedures. Validated Q-Pulse and LIMS QMS software. Cold-chain validation for the transportation of products to temperate destinations. Constructing stability profile of products. Initiated validation process for LIMS and spreadsheets. Working to update and maintain IVD manufacturing in a validated state. Given the responsibility of new Ely site validation and the move. Preparing documents for facilities, utilities, equipment, and process validation. Worked for the regulatory audits. Documentation surrounding PPQPs, IQs, OQs, and PQ for site move. Governing change controls for product scaleup and pouching. Relocation of equipment between sites. I have been involved in RO water system upgrades, Bioburden monitoring and clean-room temperature and humidity mapping. Gathering good ground-based SME-level understanding of the processes before generating documents. Working on Spreadsheet and LIMS system validation. I have also been involved in COVID-19 ELISA manufacture and tech transfer with the collaboration.
Validation Lead
Binx Health Ltd
Trowbridge
2019.02 - 2019.03
- Review and document the validation method and plan for the CT/NG Cartridge, io System and ddPCR methods. Assisted in 510k, for application and validation requirements.
QC & Validation Scientist
LGC Genomics
Hoddesdon
2016.08 - 2018.10
- Working for QC and Safety. Performing qualification and validation of equipment and consumables for genotyping. The equipment included Replicators, Meridians, Hydro cyclers, Plate Seals, Fusion and Pherastars, and consumables including 384 wells and 1536 wells PCR plates. Managed PCT plate manufacturing via a CMO.
- Performing SNPline Genotyping tests. DNA extraction and testing reagents for validation purposes. Qualify and validate assays and equipment for fluorescence-based KASP data. Approve quality and functionality of equipment and consumables before sale. Working closely with engineering for feasibility studies for new equipment and their validation to assess fit for purpose and usability. Working on high-throughput PCR for endpoint KASP and TaqMan-based SNP genotyping. Programming of liquid dispensers to reduce the use of PCR reagent to 70%, saving up to £500,000 a year. Worked with engineers to modify robot work scripts to increase performance.
Associate Scientist, Analytical Sciences
AMGEN (BIOVEX)
Abingdon
2012.06 - 2015.04
- Showcased expertise in the development and qualification of new as well as validation of existing QC analytical assays, including epitope mapping and ELISA. Assay development of HSV-based drug potency towards different cell lines. Performed reagent and method qualification/validation to compare reagents and methods from alternative suppliers. Prepared and reviewed documentation like Non-conformances, Lab investigations and Change Controls. Implantation of Lean Six Sigma practices in the laboratories. Steered targeted sequencing of HSV-based drug substance while working on the biological licence application for product characterisation and assay development. Qualified and validated qPCR-based methods using fluorescent hydrolysis probes. Managed batch-released testing and validation by an external CRO. Helped in various batch-related studies including the stability of the final drug product with stability enhancement.
Senior Research Scientist R&D Department
SCIPAC (a CMO)
2011.03 - 2012.01
- Performed upstream and downstream manufacturing and characterisation of several recombinant proteins including antibodies using 10L and 40L bioreactors. Performed process development and scale-up. Client-facing project management. Instrumental in setting up and managing an in-house cell-based assay system to identify biological activity in terms of effective dose at 50% (ED50) for in-house manufactured products such as rh EGF, FGF-1, FGF-2 and LIF. Directed development, qualification and validation of cell proliferation assays based on fluorescence-based cell proliferation testing. Provided effective training and management for transfer of biological activity assays to the QC department ensuring the sale of manufactured products valued at £100,000 with a client’s approved Certificate of Analysis. Conducted a feasibility study for the expression and production of Aspergillus oryzae FAD-dependent Glucose Dehydrogenase (FADGDH) in Pichia for an improved blood glucose quantification kit.
Research Associate Reproduction and Endocrinology
Diabetes Research Group, King’s College London
London
2009.03 - 2011.02
- Homozygosity mapping of four members of a family using 50K SNP analysis to determine the gene responsible for pancreas agenesis. Performed comparative mRNA quantification using qPCR of 672 genes from human foetal tissues from mesenchyme and kidneys. Worked on Affimetrix (ThermoFisher) SNP arrays and Illumina NGS platforms.
- Lentiviral vector-based cell engineering by expressing transcription factors like Pdx1, Ngn3 and Mafa to convert cells to Insulin-producing cells. Cell engineering to convert Human beta-cells into cancerous cell lines by expressing SV40 antigen.
Research Associate Team Leader
Randall Division, King’s College London (Viratis, a spin-off company)
London
2004.10 - 2009.02
- Hands-on experience in executing a high-end project valued at £650,000 while leading a team of five research assistants, two MSc and one PhD project students for six years. Construction of Viral Vector-based drug delivery system to target Blood PBMCs. Expression of fluorescent fusion proteins in cells and analysis using fluorescent microscopy and FACS. Further, a bio-distribution analysis of the drug product in vivo via fluorescent microscopy. Used fluorescent antibodies to stain target receptor proteins and analysed using FACS. Worked on Proof of Delivery and Proof of Concept for Drug Design and carried out Preclinical work in non-human Primates Liaised with shareholders and provided weekly project updates. Prepared work performance reports and updated GANTT charts with approved KPIs. Looking after stakeholder interest and working on risk management. Collaborated with CROs and CMOs for contracted projects. Performed tech transfer and audit of third-party CROs and CMOs. Carried out GMP manufacturing of lentiviral vector at upstream and downstream levels scale up from flasks up to 40L bioreactors. Validated CMC for the viral vector batches, using the Design of the Experiment. Worked on potential technologies and performed market analysis of novel products. Collaborated with patent attorneys to generate patent documents and perform research to investigate and respond to any infringement claims. Played a focal role in developing a drug for the depletion of HIV-1 co-receptors CCR5 and CXCR4 in human blood cells to inhibit HIV-1 infection while adhering to GLP/GMP standards. Established and enforced GLP/GMP in the laboratories. Performed qualification and validation for in-use equipment and assay techniques under ICH Guidelines. Prepared protocols and reports documentation for new equipment IQ/OQ/PQ. Conducted a study of regulatory procedures namely FDA and EMEA for evaluation of drug delivery system to be used for the first time in human clinical trials (preparation for IND meeting). This resulted in attaining proof of delivery while devising a proposal for the next phase of the project for proof of concept. Worked on drug formulation to reach drug stability and efficacy. Carried out initial studies and data acquired for clinical trials. Worked on generating Intellectual Properties and Patents for similar studies to target HBV. Furthermore, conducted studies on project potentials in terms of its viability, market interests and competition.
Education
PhD - Molecular Biology and Biophysics
King’s College London
London, UK 1996.08 - 2003.06
MSc - Analytical Chemistry
University of the Punjab
Lahore, Pakistan 1991.09 - 1994.04
BSc - Chemistry, Botany and Zoology
University of the Punjab
Lahore, Pakistan 1988.09 - 1990.03
Skills
- Proficient in Microsoft Office 365 applications
Project management software
CRM systems, including Salesforce and Zoho
Graphic design tools like CorelDRAW and Adobe Creative Suite
Data analysis software such as JMP and SigmaPlot
Workflow management with Mondaycom
Quality management with Q-Pulse - Calm under pressure
- Problem-solving
- Communication skills
- Team building
- Strategic planning
- Leadership
- Resourcefulness
- Public Relations
- Social media marketing
- Inventory management
- Multilingual
Certification
- PMP Certification Mar 2015—Apr 2016
- Greenbelt Lean Six Sigma, Zenith Lean Training, UK Jun 2012 – Jan 2015
- Attended the ‘Introduction to ISO 13485’ course.
PERSONAL DETAILS
Languages: Fluent in English, Urdu, Hindi, and Punjabi
PERSONAL DETAILS
References are available on request.
Teaching Experience
- 2004-2006 Graduate Certificate for Academic Practices (Non-award Route) Kings College London
- 1994 -2011: Leading research projects for BSc, MSc and PhD students
- 2001-2011: Running Biochemistry tutorials for Year 1 BSc and BDS students and MSc Pharmacology Lecture for MSc students.
- Jan 2007 – Aug 2016, Part time Private tutoring of GCSE and A-level students.
- Mar 1990 – Sep 1991, Preparation for Public Service Commission Examination in Pakistan.
EARLIER CAREER
- Research Scientist, Randall Division of Cell and Molecular Biophysics, School of Health and Biomedical Sciences, King’s College London, London, UK. Oct 2003 – Oct 2004
- Research Technician, Randall Institute King’s College London, School of Biomedical Sciences, King’s College London, UK. May 1994 – Aug 1996
Timeline
Senior Validation Specialist
Ceva Ridgeways Biologics
2025.03 - 2026.03
Validation Manager
Omega Diagnostics
2021.04 - 2021.01
Product Validation Manager
ANGLE Europe
2021.02 - 2024.10
Validation Lead
Binx Health Ltd
2019.02 - 2019.03
QC & Validation Scientist
LGC Genomics
2016.08 - 2018.10
Associate Scientist, Analytical Sciences
AMGEN (BIOVEX)
2012.06 - 2015.04
Senior Research Scientist R&D Department
SCIPAC (a CMO)
2011.03 - 2012.01
Research Associate Reproduction and Endocrinology
Diabetes Research Group, King’s College London
2009.03 - 2011.02
Research Associate Team Leader
Randall Division, King’s College London (Viratis, a spin-off company)
2004.10 - 2009.02
PhD - Molecular Biology and Biophysics
King’s College London
1996.08 - 2003.06
MSc - Analytical Chemistry
University of the Punjab
1991.09 - 1994.04
BSc - Chemistry, Botany and Zoology
University of the Punjab
1988.09 - 1990.03