Experience

Ascend

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• QC Senior Scientist

  • Jul 2022 - Present

  Ascend GCTx is a newly formed Contract Development Manufacturing Organisation. I was one of the first Analytical Scientists employed into the business and I was responsible for developing and implementing the strategy for QC Analytical testing on the Potters Bar site. My main responsibilities included: • Act as a wider AAV development SME across the business • Led the development of the QC testing strategy for rAAV products. • Identification of suitable contract analytical vendors and act as point of contract deliver the contract testing strategy. • Responsible for the writing of Technology Transfer documents and Method Validation documents for Analytical Methods. • Led the transfer and implementation of ddPCR at the Potters Bar site for Vector Genome Titration from the Analytical Development team in Munich. • Trained QC members on Analytical Methods. • Led the early-stage implementation and trial of Electronic BMR system. Show less



MeiraGTx

• United Kingdom
• Biotechnology
• 300 - 400 Employee

• QC Analytical Specialist - Gene Therapy

  • Mar 2021 - Jul 2022

  Responsible for the technical oversight and management of QC requirements for Gene Therapy products. Act as the technical SME for methods performed within QC and responsible for ensuring effective transfer of methods into the department from MSAT to QC. Key responsibilities include:• Leading and providing scientific and technical support during analytical method transfer within the MeiraGTx network.• Ensuring analytical methods are fit for purpose and in compliance with applicable regulations and MeiraGTx QMS.• Ensuring QC analytical method transfers are planned, effectively tracked, monitored, and achieved in accordance with agreed timelines.• Working closely with the Validation group to design validation protocol; providing support to set system suitability and sample suitability criteria based on set of data obtained during validation• Training of QC Analytical group on analytical methods.• Leading major investigations impacting QC analysis (OOS result; OOT result, Issues and CAPAs) and Change Proposals.• Supporting regulatory submissions (IND/ IMPD) ensuring they accurately reflect activities and testing performed.• Supporting PSF (Product Specification File) authoring.• Actively involved in the design of the new MeiraGTx QC laboratories in Ireland Show less

• QC Analytical Team Leader

  • Aug 2019 - Mar 2021

  Key responsibilities:• Led a team of 8 QC Analytical Scientists and QC Analysts: provided training, technical guidance, organised projects and tasks within the team, reviewed and approved QC documentation.• Scheduled lab activities: routine testing of in-process samples, drug substance and final drug product; stability trials; routine equipment calibration.• Authored/ reviewed stability protocols and reports.• Ensured adherence to QMS; led and supported Deviations and CAPAs investigations.• Supported the development and validation of gene specific qPCR assays; Western Blot; SDS-PAGE.• Transfer of analytical methods from non-GMP MSAT Labs to GMP QC Labs.• Provided QC support for collation and authoring of IMPD/IND regulatory submission.• Led extensive investigations and assigned effective corrective actions based on root cause analysis for Out of Specification results.• Led MHRA audit preparation and post-audit actions. Show less

• QC Analytical Scientist

  • Nov 2017 - Aug 2019

  • Supported the transfer of analytical test methods for rAAV from another testing laboratories to MeiraGTx: materials order, test methods protocols transfer onto MeiraGTx documentation, validation runs as part of the transfer.• Authored SOPs and forms; developed QC Assay Records to record analytical testing details, ensuring compliance with regulatory requirements.• Led and supported implementation of GMP processes within the QC Laboratories.• Supported new equipment IQOQ.• Performed various analytical tests for release and stability testing of in-process samples, drug substance and final drug product, in accordance with product specifications and as per EP and USP requirements.• Co-Led extensive investigations and assigned effective corrective actions based on root cause analysis for Out of Specification results.• Point of contact for external laboratories: testing strategy, organisation of samples shipment, results tracking.• Actively participated to the continuous improvement of the QC Department: lab organization, equipment and materials ordering. Show less



Tecrea Ltd

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Research Scientist

  • May 2015 - Nov 2017

  Tecrea Ltd is a spinout from the Royal Veterinary College, University of London and developed a novel non-toxic technology for cell and tissue delivery of reagents and drugs. • Co-led a 15-month project, part of a collaboration with Cobra Biologics, to evaluate Tecrea’s technology against the current industry standard transfection reagent for scalable AAV (Adeno Associated Virus) production. • Led a project in partnership with Toleranzia, a Sweden-based company that has developed a platform technology for treatment of autoimmune diseases. • Initiated the implementation of a biofilm assay to evaluate Tecrea’s product efficiency against Pseudomonas aeruginosa. • Formulation and characterization of nanoparticles, using Tecrea’s technology and antibiotics of interest, to increase their efficacy. Project part of the European Marie Curie IAPP project, DNA Trap, with University of East Anglia and Centre for Colloid and Surface Science (Florence). • Actively involved in the ISO 9001 certification Show less



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Cell Culture Technician

  • Dec 2014 - Apr 2015

  - Conducted manufacturing of biological products (antibodies and antigens) in mammalian cell culture, using various cell culture methods, including batch and fed-batch systems (spinner and perfusion systems, hollow fibre and wave bag systems) up to a scale of several hundred litres. - Worked with aseptic techniques using ISO Class 2 & 8. - Maintenance of accurate stock levels for inventory and non-inventory items. - Conducted manufacturing of biological products (antibodies and antigens) in mammalian cell culture, using various cell culture methods, including batch and fed-batch systems (spinner and perfusion systems, hollow fibre and wave bag systems) up to a scale of several hundred litres. - Worked with aseptic techniques using ISO Class 2 & 8. - Maintenance of accurate stock levels for inventory and non-inventory items.



Life Technologies

• United States
• Biotechnology Research
• 700 & Above Employee

• Manufacturing and Quality Control Technician

  • Nov 2011 - Aug 2013

  - Conducted manufacturing of ELISA kit reagents (components and plates), performed quality control throughout the process and on the final product and assembled the kits - Documented and reported batch failure - Organised manufacturing and quality control schedule according to the clients orders ; established priorities to meet the demands more efficiently - Put in place an inventory management for chemicals product - Implemented stability study to compare different ELISA plate manufacturing process - Assisted on the implementation of new instructions design, labels and working datasheet Show less