Mark Sanford Email and Phone Number

𝗧𝗲𝗰𝗵𝗻𝝾𝗹𝝾𝗴𝘆 𝗧𝗿𝗮𝗻𝘀𝗳𝗲𝗿 𝗮𝗻𝗱 𝗣𝗿𝝾𝗰𝗲𝘀𝘀 𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝝾𝗻:• Technical development lead for the successful transfer of three upstream processes to commercial manufacturing sites • Served as SME for upstream process performance qualification (PPQ) activities, represented technical development interests on cross-functional teams, and managed expectations of stakeholders• Conducted comprehensive facility fit and gap assessment evaluations to ensure process alignment with facility capabilities• Monitored upstream manufacturing processes and coordinated sample collection/analysis during manufacturing campaigns• Supported in-depth root cause analysis (RCA) investigations to identify and resolve complex process deviations and product quality issues• Authored technical documents, validation project plans, study protocols, manufacturing process descriptions, and summary reports• Supported health authority inspections𝗣𝗿𝝾𝗰𝗲𝘀𝘀 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝝾𝗻:• Led the design, execution, and analysis of upstream process validation studies• Applied understanding of regulatory expectations and Quality by Design (QbD) principles to process validation strategies, risk assessment, and experiment design• Authored experiment protocols, risk ranking and filtering (RRF) reports, and experiment summary reports for cell culture process validation studies• Assessed, investigated, and resolved validation study deviations𝝢𝗲𝘄 𝗧𝗲𝗰𝗵𝗻𝝾𝗹𝝾𝗴𝘆 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝝾𝗻 𝗮𝗻𝗱 𝗗𝗲𝘃𝗲𝗹𝝾𝗽𝗺𝗲𝗻𝘁 : • Drove innovation and continuous improvement by conducting laboratory experiments to evaluate new bioprocesses and technologies• Developed neural network models for in-line attribute measurements via Raman spectroscopy, validated model in scaled-down studies, authored model development method reports for GMP manufacturing implementation. Led the evaluation of Raman monitoring in microbioreactor systems

𝗣𝗿𝝾𝗰𝗲𝘀𝘀 𝗗𝗲𝘃𝗲𝗹𝝾𝗽𝗺𝗲𝗻𝘁:• Led upstream process development of 10+ new molecular entity projects through cell line screening and selection, pre-clinical toxicology material generation, and Ph I/II clinical material generation. • Served as upstream SME on cross-functional CMC teams and worked closely with downstream and analytical development groups• Designed, conducted, and analyzed cell culture experiments in lab-scale bioreactors and miniaturized systems to inform and support process optimization and large-scale process decisions• Scaled-up cell culture processes from miniature and 2L bioreactors to pilot plant and GMP manufacturing scales• Designed, conducted, and analyzed lab-scale chromatography experiments for a downstream process, scaled-up and transferred processes to pilot plant• Conducted process and equipment troubleshooting in the lab, pilot plant, and GMP manufacturing. plant.• Presented data and communicated recommendations to management, CMC teams, and various review committees• Authored internal development reports and IND regulatory document sections • Reviewed and approved changes to manufacturing tickets and MES recipe templates• Continuously evolved workflows to increase efficiency and reduce timelines𝝢𝗲𝘄 𝗧𝗲𝗰𝗵𝗻𝝾𝗹𝝾𝗴𝘆 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝝾𝗻 𝗮𝗻𝗱 𝗗𝗲𝘃𝗲𝗹𝝾𝗽𝗺𝗲𝗻𝘁: • Product quality modulation - Evaluated media components and process parameters to identify levers for shifting product quality attributes• CHO cell line stability - optimized assays to determine cell line stability and developed a quantification method to track stability trends across cell line development projects