Dr. Edward O’Connor has over thirty years of experience in the clinical chemistry world. He has held executive and management position at Alexion Pharmaceuticals, Frontage Labs, Elusys Therapeutics, Biogen, MedImmune, Therimmune Research, Covance Labs, Microtest, Oread, and TSI Mason.  He has been a research assistant professor and  adjunct professor in the Physiology and in the PsychologyDepartments at the University of Tennessee, Knoxville, and an Hitchcock and NIH Fellow at the Dartmouth Hitchcock School of Medicine. Dr. O’Connor earned his doctorate in Zoology (Neuroendocrinology) from the University of Massachusetts at Amherst.

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Notable achievements:

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• First validation of a semi quantitative microbiological assay, including linearity, accuracy, precision, specificity, dilutional linearity. 

• Developed and validated ATA assay format to permit quantitation of cut point equivalent in ng/mL.

• Developed and validated LC-UV method for the measurement of 29 merantisense oligomer in serum.

• Developed and validated LC-UV method for 29 mer antisense oligomer packaged in lecithin based liposome.

• First Validation of a quantitative assay for an RNA aptamer to VEGF using dual hybridization and chemiluminescence detection.

• Disciplined selection of a LC-MS/MS to support intact large molecule (antibody) quantitative analysis (Sciex 6600).

Dr. Scott Jeffers is a Scientific leader with >20 years of experience in viral gene therapy, virology, biochemistry, and molecular biology. He is an expert in using novel technologies (single-use bioreactors, ATF perfusion systems) to produce clinical and commercial-stage drug products for rare monogenetic diseases.  He is also a proven cross-functional team leader of global matrix teams of more than 25 group leaders, senior/junior scientists and engineers, and technicians (upstream and downstream manufacturing and process development, QC, QA, RA, CMC leads, non-clinical, clinical, R&D, and Engineering) to complete projects.  Dr. Jeffers is an expert in troubleshooting and problem-solving complex technical issues across processes while working closely with biotech and pharma companies to implement innovative technologies including ultracentrifugation, monolith and membrane absorbers, and affinity chromatography.

Stefanie Heinrich has more than 15 years of research and development experience in biochemistry and human genetics. She has worked in university hospitals in Germany performing association studies and diagnostics. She was on the Scientific Advisory Board of a Nutrigenomics company and has been working as a Director of Genetics for Precision Medicine companies developing i.a. Nutrigenomics and Pharmacogenomics products. She has a diploma in Biochemistry from the Ruhr-University, Bochum, as well as a doctoral degree of natural sciences from the Ludwig-Maximilan-University, Munich, department of Pharmacy and Chemistry.

Dr. Raymond Kester is a Principal and founder of Strategic Quality Leadership Resources, LLC. a premier technical leadership consulting team comprised of highly accomplished scientists, engineers, and analytical professionals specializing in leadership skills to bring complex ideas and vision into reality through extraordinary program/project leadership.

Dr Kester has an unrivaled ability to bring high-talent people together creating create executable plans and collaborative skills to achieve prompt results in new frontier and transitional projects.

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He has delivered efficient, compliant, and lasting business systems and technical solutions in regulated FDA /ISO environments (Medical Devices, BioPharma, Viral Vector/Gene Therapy) including:

• Product/process Validations – Planning, execution, and documentation

• Manufacturing processes, sterilization, computer systems, and environmental (cleanroom, BSC, WFI, Chromatography processes, etc.)

• Quality System/ Operational system setup/ remediation

• Laboratory and Operational Systems (QMS, LIMS, and ERP)

• Holding the gains through the right metrics- monitoring, trending, and KPIs to drive continuous improvement and ensure efficient compliance.

Kapeeleshwar Krishana is an Ivy League educated Physicist, who is always looking for simplicity and improving efficiency in a process.   By analyzing a process from a physics point of view, Kapeel can innovate the parts that do not require biochemical reactions. Often, a cell, antibody, or ligand will undergo a physical change that can be detected in the physical properties of the system, such as opacity/flow properties/color change/rigidity. Kapeel has investigated such properties and challenges to such measurements on several occasions. He also holds an MBA and is known for exceptional customer service. He brings these qualities along with a ‘can-do attitude and a constant desire to learn to help the company.

Dr. Manish Mittal is a recognized scientific leader in Biomedical and Healthcare Sciences with highly cited research publications and grant awards from the American Heart Association. He has served as Assistant Professor of Research in the Department of Pharmacology at the University of Illinois Chicago where he was actively involved in investigating the role of macrophage plasticity in modulating Acute Lung Injury response and development of cell-based therapies for the treatment of pulmonary vascular diseases. He has authored multiple research papers in the areas of Pulmonary Arterial Hypertension (PAH), Endothelial and Stem cell biology,  and has spoken on several occasions at international conferences. He is currently leading the team of Data Scientists at Interoperability Institute in Ann Arbor, Michigan, and is involved in developing computational tools and technologies in the healthcare arena to improve patient care quality and outcomes. Dr. Mittal obtained his doctorate in Molecular Biology from Justus Liebig University, Germany. He has a Master of Science degree from the University of Edinburgh, (U.K), and a Master in Health Informatics from the University of Illinois Chicago, USA. 

Ben Osorio is a pharmaceutical quality professional with comprehensive experience and an increasing scope of responsibility with development and commercial pharmaceutical/biopharmaceutical organizations.  Successful track record of leading quality organizations, building and enhancing quality systems, managing pre-approval readiness activities for newly launched products and product expansions, and leading compliance remediation efforts.