Stephen Pepper Email & Phone Number

London, Gb

FDA BLA Filing & Approval -Planned, led and delivered the CMC Module 3 of the Obe-cel BLA for the FDA, executing a plan across 3 years that was completed on time-This involved providing the daily activities for a team of over 50+ Authors, SMEs, contracted technical writers and senior leaders, as well as leveraging the existing CMC process to find clear paths forward for BLA section content (content "deep dives" and gap analysis)-Managed the FDA Information Request process, which involved leading a rapid response team to triage and generate responses to the FDA questions within a short timeline -Provided content for and participated in meetings with the FDA (Late Cycle, Informal, Type B/C)MHRA MAA Filing-Planned, led and delivered the CMC Module 3 of the Obe-cel MAA for the MHRAEMA MAA Filing-Planned, supported and delivered the CMC Module 3 of the Obe-cel MAA for the EMA-Managed the D120 List of Questions process for providing responses to the EMA -Responsible for authoring some of the responses for EMAProcess Development Leadership Team-Member of the PDLT -Participated in strategic planning for pipeline programs and leveraged the existing CMC process structure to progress the product development-Managed the CMC Advisory boards, which contributed to the overall CMC strategy-Provided overall project governance for process development projects that contributed to the Obe-Cel BLA & Pipeline projects

London, Gb

-Created and managed the CMC process, which involved leading a matrix team of 25+ CMC leaders across all functions to cover risks, decision making and escalation of key business-critical topics to senior leadership for ex vivo gene therapy products -Planned, managed and executed the process characterisation, analytical procedure validation and process performance qualification (PPQ) of our lentiviral vector with our CDMO partner-Identified and implemented a project management software system and ways of working for the Product Delivery function within Autolus (250+ people). -Drafted a detailed plan to deliver the BLA CMC Module 3 for the Obe-cel across a 2-year timeline

London, Gb

Key Achievements -Led a team of scientists for the initial development of a validated scale-down model for the Obe-cel process. This scale-down model was used for the process characterisation campaign that supports the Obe cel BLA filing-Characterisation of the Obe-cel process utilising the Miltenyi Prodigy-Led and executed 5S initiatives to restructure the process development laboratories and streamline the workflows

Dublin, Dublin, Ie

Key Achievements:Lead on process development for scaling our process to a level suitable for Clinical applications in the field of CAR-T and other Advanced therapy medicinal products with a GMP aligned model. Conducted detailed characterisation of our process and spray applications which facilitated increased efficiency of payload delivery without affecting cell viability or proliferative capacity.Introduced and manged a digital Quality Management System to replace our paper based system. This involved mapping our all critical processes, establishing robust standard operating procedures and associated documentation to create a GMP & GLP aligned strategy for Quality Management.Designed, implemented and continue to manage a project management system using Wrike, that allows planning and task delegation for a cross-discipline team over multiple internal and external projects as well as creating the framework and processes for managing an EU funded H2020 grant to the value of €2.1 million. Developed an implemented an Agile-Traditional Hybrid Project Management approach to the design and execution of experiments and R&D work packages. Created the "Avectas Social Club" which focuses on providing wellness activities for all employees such as yoga as well providing healthy snacks and beverages.

Dublin, Dublin, Ie

Key Achievements:Lead Scientist on Process Development of our Flow Technology Programme. This involved using a novel vector free delivery technology of therapeutically relevant payloads; such as Cas 9 RNP and mRNA, MegaTALs, siRNA and plasmids to Mesenchymal Stem Cells & multiple immortalized cell lines as well as Chimeric Antigen Receptors to T-Cells.Experience culturing, manipulating and transfecting multiple cells lines including, but not limited to; PBMCs, CD3+ T-cell populations, Mesenchymal Stem Cells, Hematopoietic Stem Cells, Jurkats, A549s and U-2 OS using Electroporation, Nucleofection, Lipofection and Novel Vector Free methods. Extensive experience with multiple analytical techniques including, but not limited to, Flow Cytometry, Western Blotting, Fluorescent Microscopy, Digital Droplet PCR, PCR, ELISA and Cell Viability Assays.Responsible for overseeing multiple internal Health & Safety audits and conducting a full overhaul of our health & safety system. This involved creating new policies and SOPs to capture our processes as well as streamlining our Risk Assessments and SDSs to an electronic format. Responsible for ordering all capital equipment and consumables through implementing a cloud-based solution called Quartzy for streamlining our ordering, spend control and inventory management. Saved > €25,000 on equipment and critical consumables through negotiating with suppliers.

Key Achievements:Conducted Phase 2 to Phase 3 scale up process development while maintaining GMP standards of operation. This involved developing the process for a larger mixing vessel and leading all of the initial test runs. From this I was responsible for training all new employees involved in the manufacturing division, conducting window studies to determine the tolerances of the process and developing the relevant document to be submitted to the FDA. Characterization of Silicone and API material properties which were used in the Phase 3 mixing process using Rheology, Differential Scanning Calorimetry, HPLC and Scanning Electron Microscopy. Extensive operational experience in GMP clean room settings while adhering to strict FDA stipulations for operation.

6 month internship positionKey Achievements:Evaluated the comparative efficacy of using a UV Spectrophotometer Microplate Reader as an alternative to the current HPLC method of API release rate quantification and content uniformity. Provided a quicker, equally complaint method to replace the HPLC quantification.Summarized experimental data and created test reports discussing the results and their implications.Conducted suitability testing for new packing for manufacturing methods and provided detailed observations on package integrity and response to dose mapping for irradiation.Conducted preventative maintenance and calibration on a multitude of equipment including, but not limited to, Dual Asymmetric Mixers, Analytical Balances, Vacuum Pumps, Rheometers and Differential Scanning Calorimeters.

Maynooth, Co. Kildare, Ie

Development and demonstration of industry driven research methodology.Acquired thorough experience in a multitude of cross discipline research techniques.Responsible for preparation and application of all experimental reagents and compounds.Recognised by senior lecturers for competency in execution of the methodology.Correction of lab assessment and providing detailed feedback.Contributing to the development and improvement of practical’s.

Maynooth, Co. Kildare, Ie

Final year research project Investigating Pellino proteins in an effort to design new Immunomodulatory DrugsCreated a viral challenge in HEK293 & U373 cells using synthetic ds RNA to determine the effect of pharmacophore mimetics of Pellino 3 on IRF-7 production. Determined a dose depended response of each mimetic on the production of IRF-7 by transfecting a luciferase reporter plasmid. Utilised ELISA to quantify RANTES cytokine production and therefore determine the effect each mimetic had on downstream immune response.Evaluated cytotoxicity and optimum dosage through MTT cell viability assay.

Bachelor Of Science (Bs), Biological And Biomedical Sciences

Education record