Scott Faulkner Email & Phone Number

Gaithersburg, Maryland, United States

Gaithersburg, Maryland, United States

Member of a newly formed manufacturing team at BioNTech Clinical site dedicated to developmentof neoantigen-specific, personalized T-cell therapies on solid tumors in an aseptic clinical environment. Worked in conjunction withProcess Development and Research in creating new manufacturing processes utilizing innovative technologies. Performed T-cell processing using the CliniMACS Prodigy automated cell processing system. Created new Standard Operation Procedures, Work Instructions, and Manufacturing Training Modules during technology transfer. Lead training workstream for manufacturing during startup of new BioNTech facility. Trained entire new manufacturing staff on manufacturing equipment and processes. Attended Miltenyi University on CliniMACS Prodigy TCT User training.

Gaithersburg, Maryland, United States

Member of a small tech transfer team at the NeoAntigen Facility dedicated to producing Retroviral vector and T Cell cancer therapies in an aseptic cGMP clinical environment. Aseptic work done in an ISO5/ISO7 cGMP environment with CellSTACK culture vessels, 10L Xuri bioreactor systems, SEPAX cell separation system, and CliniMACS cell separation system.Operate production equipment while strictly following Manufacturing Production Records in accordance with SOP’ and cGMP guidelines.Perform various support roles for all manufacturing processes.Utilized Lean Six-Sigma and 5S methodologies to continuously improve the GMP Manufacturing suites,

El Segundo, California

Fully trained and qualified Cell Therapy Specialist II, performing all tasks associated with the manufacturing of CAR-T cells, including isolation, retroviral transduction and expansion while maintaining aseptic conditions within an ISO7, ISO 8 and ISO5 cleanroom cGMP environment.

Ccp1 Purification Operations Group 2002-2004, 2011-2013, 2017

Master Bioprocess Technician, 2004 - 2017Produced innovative biopharmaceutical medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, while maintaining areas in high state of inspection preparedness.• Prepared Work Orders, Automation Change Requests, SOP’s, and Training Procedures.• Completed startup and performed validation testing of column packing, buffer tanks, bay skids and Urea-deionizing systems operations for on-site product campaigns.• Served as department representative and Subject Matter Expert (SME) working with departments and outside vendors on project teams. • Recommended and determined solutions to resolve processing issues and equipment failures, including replacing existing valve configuration with jumper panel between final process steps to allow both process steps to run simultaneously instead of subsequently. Recommended upgrading Mac valves on Freeze-Thaw system to improve reliability.• Trained department and shift staff in all aspects of recovery processes and GMP compliance, which helped with greater productivity, improved problem solving, and more effective use of resources.• Act as SME on Column Packing, Freeze Thaw System, NaOH Sanitization system and CIP System.• Served as Manufacturing representative on Freeze-Thaw Reliability Team, a cross-functional team that identified underlying issues related to adverse skid operations and provided recommendations to mitigate issues that improved the success rate of the freeze thaw system by 20%. • Act as Safety Team Lead. Assisted in instituting Injury Free Workplace (IFW) program on site; addresses safety concerns prior to incidents occurring.• Certified Trainer and Certified FIT inspector.

Manufacturing Initiatives Group, Site Portfolio Team

Served as primary manufacturing Point of Contact (POC) for project activities on site.• Acted as system owner for Buffer Tank replacement and Vent Line Cleaning modifications – completed on time and in budget.• UFDF Microbrial Control Study. Benchmarked cleaning procedures with South San Francisco and Oceanside sites, modified equipment and procedures; reduced microbrial excursions during processing. • Developed protocol to measure process characteristics, and assisted with creation of new non-product specific post-use recipe. Identified and implemented throughout Roche network. • Gentamicin Removal project. Redesigned and validated Affinity chromatography step pre-use recipe to accommodate the removal of Gentamicin from the process stream.• Incident Free Lots Study – Chromatography Column Design Team – Penzberg, Germany. Developed methods to characterize each column type across network with regard to bioburden, dead spots, diffusion times, adequate flow distribution, turbulent flow rates and sanitization effectiveness of design.• Actemra tech transfer project. Provided expertise in benchmarking product column packing procedures during tech transfer from Oceanside site to Vacaville site to streamline procedures and standardize operations across network.

Manufacturing Initiative Group

Participated in the technology transfer and startup of new product line.• Served as system lead for Column Packing System. • Worked on site at Chugai Pharmaceuticals, Utsunomiya Japan, with MSATS and outside vendors to bring in new types of resin not previously used by Genentech, and developed new methodologies to pack and unpack columns.Worked with MSATS and outside vendors in developing new recipes and protocols for column packing of new types of resins to be used in production of new molecules.

Ccp2 Client Team, Downstream

Participated in starting up new production facility.• Served as System Lead and SME for new Automated Column Packing System and for Buffer Prep, Buffer Bag, and Freeze Thaw System • Scheduled debug activities, allocated resources, and coordinated all activities to column packing system.• Completed startup and performed debug testing and validation of the column packing and bay skids operations for product campaigns.• Authored Protocols, SOP’s, and Training guides.• Participated in recipe design, AFR revisions, and graphic design of new HMI displays.• Worked with Product Development in designing new methodologies for packing andunpacking column operations within a closed system.

Bachelor Of Science (B.Sc.), Chemistry

Activities and Societies: American Chemical Society

Certificate In Project Management