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.

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.

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.
• 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.
• 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.

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.

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.

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.

Bachelor Of Science (B.Sc.), Chemistry

Activities and Societies: American Chemical Society

Certificate In Project Management