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 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 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 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.
Jeanette Young, PhD joined BioTechLogic in June 2018. Prior to BioTechLogic, Jeanette worked at Spark Therapeutics, where she was a Quality Control Scientist in the Technical Operations Department. While at Spark, Jeanette served as a leader in cell-based bioassay methods and the development and validation of bioassays, identity assays, and residual DNA and protein assays. Jeanette was a part of the team of scientists who contributed to the first approved gene therapy product for an inherited disease by the FDA. As a Senior Consultant, Jeanette will support clients by providing support on the development, qualification, transfer, and 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.
Mike Berry, PhD has more than 25 years of industrial experience working for companies such as MedImmune, Novartis, Dynavax, Portola Pharmaceuticals and Sanofi. Mike provides clients with technical expertise and strategic planning for projects involving process and analytical method development and validation, tech transfer and scale-up, yield improvements, technical support for manufacturing and QC and supply chain. He can provide services for recombinant microbial and mammalian expression systems as well as chemically synthesized oligonucleotides and peptides. His expertise covers cell line development, cell banking, fermentation, chemical synthesis, primary recovery, purification, formulation, and parenteral drug product fill/finish including aseptic processing. Mike has also led multiple statistically driven yield improvement projects resulting in substantial increases and more robust processes.
He also has extensive experience with analytical methods for product release, in-process control and product characterization. Mike has an extremely strong knowledge of cGMP and regulatory expectations and has been a key player in multiple face-to-face, teleconferences bi-annual inspections and pre-license inspections with FDA, EMA and ISO inspectors. Mike has a B.Sc. in Biotechnology from the DeMontfort University in the UK, an M.Sc. in Bioreactor Systems from UMIST in the UK and a Ph.D. in Biochemical Engineering/Microbiology from the University of Manitoba in Canada.
Ted Condez joined BioTechLogic in September 2019 with a focus on medical device delivery systems. Ted has over 15 years of experience in the medical device industry and has held both technical and management roles supporting various technologies including neuro and cardio implants, catheter delivery systems, and medical electrical equipment. He also has experience in combination product quality systems and design quality assurance. As a Senior Consultant, Ted’s primary responsibility is to provide support to combination product projects with focus on design controls, design verification and validation, design reviews, design transfer, design dossier/technical file writing, and quality systems development. Ted holds a B.S. in Health Sciences from California State University Hayward and has completed graduate courses in Systems Engineering from Embry Riddle Aeronautical University.
