Our Team of Senior Consultants

BioTechLogic’s highly skilled professionals work alongside your staff and resources throughout the course of your project. We blend as teammates into your organization; we not only serve as the technical expert and consultant, but also provide hands-on leadership to drive and successfully execute the plan.

David Fetterolf
David Fetterolf has 17 years of experience in the biopharmaceutical industry. He has held process development, manufacturing and validation positions at Covance Biotechnology Services, Diosynth (Akzo Nobel), Pharmacia and Pfizer, where he managed API and Drug Product manufacturing technologies, technology relocation and scale-up, validation, and product supply chains at internal and third-party manufacturing sites. He holds a B.S. in Chemical Engineering from Pennsylvania State University and an M.B.A. from Elon University.

Julie Spyrison
Julie Spyrison joined BioTechLogic in 2004 with a focus on CMC Regulatory and Project Management activities.  Julie has over 14 years of experience in the biopharmaceutical industry.  As part of the BioTechLogic team, Julie is responsible for managing CMC Regulatory submission projects and preparation of CMC documentation.  As part of the dossier preparation and its lifecycle management, Julie performs source document gap analyses, prepares Agency briefing packages, prepares Module 2.3 and Module 3 CTD sections, authors responses to Agency questions, facilitates the electronic publishing process, and evaluates change control requests post-dossier submission for Regulatory impact.  Julie also provides clients with project management support for multiple Drug Substance and Drug Product technologies. Responsibilities include management of activities associated with the Drug Substance and Drug Product contract manufacturing sites, process scale-up and technology transfer, process validation, regulatory submission packages, and global regulatory inspection readiness.  Previously, she was a project manager at Integrated Project Management Company, Inc. During her tenure there she managed projects at Searle, Pharmacia and Pfizer, related to business process improvement initiatives and program management of product development projects, including deliverables related to Drug Substance and Drug Product manufacturing, analytical technology development, and preparation of CMC regulatory submissions.  She holds a B.S. in Chemical Engineering from Northwestern University.

Rachel Houp has over 15 years of experience in the biopharmaceutical industry. Her responsibilities at BioTechLogic include validation, preparation of CMC regulatory documentation submissions, quality assurance and project management support. Rachel has also gained experience in equipment qualifications. Her specialties include Process Validation over the lifecycle of the process/product, support validations and IND, IMPD, BLA, MAA and PAS CMC submissions in the CTD format. Previously, she held positions in quality assurance, validation, small scale cell culture manufacturing and QC testing at Human Genome Sciences, Diosynth (Akzo Nobel), Covance Biotechnology Services, BioReliance, and Tektagen. As part of the BioTechLogic team, Rachel provides API and Drug Product manufacturing and project support for clients with protein, vaccine, oligonucleotide and synthetic blood products. Rachel holds a B.S in Biology, with a concentration in Molecular Biology and Biotechnology from East Carolina University.

John Kandl - BioTechLogic
John Kandl joined BioTechLogic in 2008 with a focus on contract manufacturing management, process development, and validation activities.  John has over 14 years of experience in the biopharmaceutical industry. He has previously held Quality Assurance positions at Exelixis and Tercica, Inc where he maintained oversight of the contract manufacturing for numerous APIs and drug products, developed corporate quality systems, validation programs, and regulatory submissions. Prior to this John was a Project Engineer with SAVIS Inc. a consulting firm for the pharmaceutical/biotechnology industry. At SAVIS, John led numerous analytical, equipment, computer, cleaning, and process validation projects. John holds a B.S. in Chemical Engineering from the University of Missouri.

Michael Boyne, PhD. joined BioTechLogic from the US Food and Drug Administration in May 2015 where he was a Research Chemist in the Division of Pharmaceutical Analysis. As a Senior Consultant, Michael will support clients by providing expert advice on the establishment of analytical similarity for drug products using the 351 (k) pathway including protocols and requirements for statistical analysis, support the development, qualification, or validation of analytical methods used to characterize, identify, and establish the quality of intermediates, drug substances, or drug products, and draft, review, author and perform expert reviews of Pharmaceutical Quality/CMC sections (Module 3) of the CTD for regulatory submissions.

While with the agency, Michael served as an expert in bioanalytical chemistry and the development and validation/qualification of bioassays, chromatography, mass spectrometry, and spectroscopy methods used for structure elucidation of complex drug products (naturally derived and biologics), for the identification and characterization of impurities and degradation products, and for evaluating the quality of US marketplace drugs. He has authored over 30 peer-reviewed publications and is an internationally recognized speaker on the application of modern analytical technologies to the evaluation of biotechnology products. Prior to joining the FDA, Michael was a postdoctoral scholar at Washington University Medical School in Saint Louis in Oncology. Michael has a BA in Chemistry from Northwestern University, Evanston, IL and a PhD in Chemistry from the University of Illinois Urbana-Champaign.