Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Staff Engineer (Principal Engineer) (Manager)

  • Jan 2022 - Present

  Late Stage Cell Culture Development, a part of Preclinical Manufacturing and Process Development. • Lead team of Process Engineers to develop upstream commercial processes for large-scale molecules (biologics) through Quality by Design (QbD) approach • Assess cell lines and optimize culture processing to increase productivity and improve product quality attributes (pCQA and pGQA) through small-scale design of experiments (DOE) • Statistically determine final processing setpoints… Show more Late Stage Cell Culture Development, a part of Preclinical Manufacturing and Process Development. • Lead team of Process Engineers to develop upstream commercial processes for large-scale molecules (biologics) through Quality by Design (QbD) approach • Assess cell lines and optimize culture processing to increase productivity and improve product quality attributes (pCQA and pGQA) through small-scale design of experiments (DOE) • Statistically determine final processing setpoints for robust operating space and identify critical process parameters (CPPs) using linear regression, stepwise, and Monte Carlo simulations • Conduct risk assessments of antibody manufacturing processes using QTPP, unit operation risk assessments, and PFMEAS • Guide initial tech transfer and validation (PPQ) manufacturing campaigns to 2000L and 10,000L manufacturing site via manufacturing record reviews, PPQ report review, and PAR report reviews • Investigate variability in bioreactor performance across scales and leverage scale-down models to accurately predict performance at manufacturing scale • Direct innovative technology development project timelines and resourcing within department and implementation across manufacturing sites • Author and review Quality Attribute Risk Assessments (QARA) and CMC regulatory filing documents (IND, BLA)

• Process Development Engineer III (Associate Manager)

  • Jan 2018 - Dec 2021

  Media Development within the Cell Culture Development group, a part of Preclinical Manufacturing and Process Development. • Manage team of full-time employees and co-op students in experimental design, lab techniques, and statistical analysis while coaching development areas to build strong foundational skills and behavioral competencies • Direct innovative medium development project timelines and resourcing for monoclonal antibody processes (fed-batch and perfusion) • Advance… Show more Media Development within the Cell Culture Development group, a part of Preclinical Manufacturing and Process Development. • Manage team of full-time employees and co-op students in experimental design, lab techniques, and statistical analysis while coaching development areas to build strong foundational skills and behavioral competencies • Direct innovative medium development project timelines and resourcing for monoclonal antibody processes (fed-batch and perfusion) • Advance novel nutrient strategies to increase productivity and improve product quality attributes (pCQA and pGQA) for late-stage programs • Lead person in-plant (PIP) and virtual manufacturing support for custom media, feed, and buffer hydrations with cross-functional collaboration to internal, external, and international facilities • Adapt medium and feed hydration procedures to accommodate manufacturing equipment, constraints, and scales to ensure successful preparations to support 500L, 2000L, 10000L, and 25000L processes • Author technical documents including manufacturing process transmittals, reports and memos, and CMC regulatory filing documents (IND, BLA)

• Process Development Engineer II

  • Jan 2016 - Dec 2017

  • Develop high-throughput, small-scale models to rapidly optimize custom nutrient strategies for high productivity cell lines • Model amino acid consumption and metabolic profiles of cell lines to advance custom nutrient strategies for clinical (20+ processes) and commercial (5 agency approved) programs • Support technology transfer of proprietary medium and feed formulations to GMP manufacturing through project management

• Process Development Engineer I

  • Jul 2013 - Dec 2015

  • Research, design, and analyze fed-batch and perfusion medium development experiments via multivariate statistics (JMP/DOE) • Optimize nutrient strategies for CHO cells (biologics) to improve cell growth, cell productivity, and product quality • Manage co-op students in lab techniques and statistical analysis



Lehigh University

• United States
• Higher Education
• 700 & Above Employee

• Graduate Research Assistant in Biomaterials Laboratory

  • Aug 2011 - Jul 2013

  • Optimized growth conditions for mammalian cell lines and stem cells including: hMSCs, C17.2s, MC3T3s, P19s, NIH3T3s • Investigated cell-surface interactions and mechanotransduction through biomaterial platforms • Quantified protein and mRNA expression via immunocytochemistry and qRT-PCR THESIS: The Extracellular Environment's Effect on Cellular Processes: An In Vitro Study of Mechanical and Chemical Cues on Human Mesenchymal Stem Cells and C17.2 Neural Stem… Show more • Optimized growth conditions for mammalian cell lines and stem cells including: hMSCs, C17.2s, MC3T3s, P19s, NIH3T3s • Investigated cell-surface interactions and mechanotransduction through biomaterial platforms • Quantified protein and mRNA expression via immunocytochemistry and qRT-PCR THESIS: The Extracellular Environment's Effect on Cellular Processes: An In Vitro Study of Mechanical and Chemical Cues on Human Mesenchymal Stem Cells and C17.2 Neural Stem Cells http://preserve.lehigh.edu/etd/1448/ PUBLICATIONS: • LeBlon, C.E., Casey, M.E., Fodor, C.R., Zhang, T., Zhang, X., Jedlicka, S.S., "Correlation between in vitro expansion-related cell stiffening and differentiation potential of human mesenchymal stem cells," Differentiation, September 2015. • Rodgers, J.W., Casey, M.E., Jedlicka, S. and Coulter, J.P., “Effect of Micro-Injection Molding Processing Conditions on the Replication and Consistency of a Dense Network of High Aspect Ratio Microstructures,” Journal of Micro and Nano-Manufacturing, February 2014. Proceedings Papers: • Rodgers, J.W., Casey, M.E., Jedlicka, S. and Coulter, J.P., “Micro Injection Molded Microtopographic Polymer Plates Used to Mechanically Direct Stem Cell Activity,” 8th International Conference on MicroManufacturing 2013 Meeting, Victoria, British Columbia, Canada, March 2013. • Casey, M.E., Rodgers, J.W., LeBlon, C.E., Coulter, J.P. and Jedlicka, S. “Micro-injection Molded Polymeric Surfaces for the Maintenance of Human Mesenchymal Stem Cells (hMSCs),” Proceedings of the Materials Research Society Fall 2012 Meeting, Boston, Nov 2012. • Casey, M.E., Ventura, A.P., Misiolek, W.Z. and Jedlicka, S. “Anodic Aluminum Oxide (AAO) Membranes for Directed Neurite Outgrowth,” Proceedings of the Materials Research Society Fall 2012 Meeting, Boston, Nov 2012. • Casey, M.E. and Jedlicka, S. “Neuronal Outgrowth and Differentiation on Poly (glycerol sebacate),” Proceedings of the Materials Research Society Fall 2011 Meeting, Boston, Nov 2011.

• Teaching Assistant

  • Aug 2012 - Dec 2012

  Integrated Biostructural Mechanics Laboratory (BioE 357) • Designed and prepared bioengineering applications-based research experiments for undergraduates • Prepared corresponding lectures for laboratory experiments • Taught and advised students on laboratory techniques, including microscopy and aseptic technique



Lehigh University

• United States
• Higher Education
• 700 & Above Employee

• Admissions Fellow

  • Jul 2010 - May 2011

  • Conducted admissions interviews and gave campus tours to prospective students • Represented Lehigh University at regional college fairs • Conducted admissions interviews and gave campus tours to prospective students • Represented Lehigh University at regional college fairs