Tracy TreDenick

Head of Regulatory and Quality, and Senior Consultant

Tracy joined BioTechLogic in 2004 as the Head of Quality and Regulatory. She has over 28 years of experience in Pharmaceutical Quality, Manufacturing and Regulatory.

Most recently she has performed multi-product facility audits with additional pre and post-viral clearance requirements, global commercialization and submission readiness assessments, and prepared several U.S. and Europe Chemistry, Manufacturing, and Control sections in the CTD format for an adjuvanted vaccine, combination product, and biosimilar. This responsibility included the preparation of documents that spanned the course of process development, clinical and commercial-scale manufacturing for both the Drug Substance and Drug Product. This experience enabled a full understanding of the expectations for development, manufacturing, and analytical characterization of the product to obtain global product approval.

Prior to joining BioTechLogic, Ms. TreDenick directed the validation and pre-approval readiness programs for biopharmaceutical products within Pfizer (formerly Pharmacia Corporation), including the process validation, registration, and commercialization of Somavert®, a well-characterized recombinant protein product.

From 2000 to 2002, Ms. TreDenick was Manager – Global Quality and Compliance for G.D. Searle, a division of Monsanto. During this time she was involved in the quality and regulatory review of women’s health care products. Prior to joining G.D. Searle, Ms. TreDenick had roles with increasing Quality Assurance responsibility for SoloPak Pharmaceuticals and Baxter Health Care that supported drug product Aseptic filling operations.

Ms. TreDenick received her B.A. in Biology/Pre-Med from Indiana Wesleyan University. She also completed graduate study courses in Business Management at Keller Graduate School of Management.

Patrick Giljum

Head of Operations and Senior Consultant

Patrick Giljum joined BioTechLogic in 2004 as the Head of Operations. He has over 27 years of experience in biopharmaceutical process development and cGMP manufacturing of clinical and commercial supplies, supporting multiple Drug Substance and Drug Product technologies. Most recently, he supported the process validation, registration, and commercialization of an adjuvanted vaccine filed in both the US and Europe.

Prior to joining BioTechLogic, Mr. Giljum directed the manufacturing operations for clinical supply, registration, and ongoing commercial supply of biopharmaceutical products within Pfizer (and the former Pharmacia Corporation), including the process validation, registration, and commercialization of Somavert®.

From 1993-1999, Mr. Giljum was involved in the development of multiple Cytokine protein products for G.D. Searle, a division of Monsanto, including molecular biology, synthesis and purification, technology relocation, process validation, and the production of clinical and launch supplies.

From 1991 to 1993, Mr. Giljum supported the molecular biology and fermentation technology for the commercialization of Posilac®, Bovine Somatotropin, with Monsanto, Animal Science Division.

Mr. Giljum received his B.A. in Biology/Microbiology and completed graduate studies in Medical Physiology and Molecular Biology at St. Louis University.

David Fetterolf

Director, Technical Operations & Senior Consultant

David has more than 20 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

Director, Regulatory Operations & Senior Consultant

Julie joined BioTechLogic in 2004 with a focus on CMC Regulatory and Project Management activities.  Julie has over 20 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

Senior Consultant

Rachel has over 20 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

Senior Consultant

John joined BioTechLogic in 2008 with a focus on contract manufacturing management, process development, and validation activities.  John has over 20 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.

Eileen Choi, PhD

Senior Consultant

Eileen joined BioTechLogic as a Senior Consultant, Technical Operations in 2019 with more than 20 years of experience working in the biopharmaceutical and chemical engineering fields. Her role at BioTechLogic includes providing consulting services in all areas of technical operations including process and analytical method development and validation. She also provides project management and manufacturing support, process validation expertise, support for the development, qualification and validation of analytical methods including analytical method validation of intermediates for clients with antibody, antibody conjugates, recombinant protein, and blood-based products. Additionally, she supports validation activities for biologics clients, such as in-process/media/buffer/solution hold time studies, chromatography and TFF membrane re-use studies, shipping validation, filter validation, and leachables/extractables risk assessments for both in-process product contact material and container closure systems. Her role also includes leading remediation projects to enhance compliance for manufacturing processes and analytical methods in support of manufacturing and quality control of various products.

She earned a Ph.D., Chemical Engineering with emphasis in Molecular Biology and Bioscience form Michigan Technology University, Houghton, MI. Eileen earned her B.S., Chemical Engineering, also from Michigan Technology University.

Ariel Bornstein

Senior Consultant

Ariel joined BioTechLogic in 2020 and has over 15 years of experience in the biopharmaceutical industry. He has held positions in process development, MSAT, commercial manufacturing operations, and technical writing in the recombinant protein, plasma product, and oligonucleotide drug substance and drug product manufacturing fields. His primary consulting responsibilities involve technical and manufacturing operations support, process development and validation activities, process risk assessment, authoring and review of technical reports, batch records, SOPs, and other supporting documents.

Additionally, Ariel supports validation activities for biologics clients, including hold time studies, resin and membrane re-use studies, shipping studies, filter validation, and extractables & leachables assessments. Ariel is a graduate of Brandeis University.

Ashley Gucinski, PhD

Senior Consultant

Ashley Gucinski, PhD returned to BioTechLogic in 2021 after two years at COUR Pharmaceuticals, serving most recently as the Vice President of Operations and Quality. As a Senior Consultant in Analytical Services, Ashley supports clients in a variety of areas. She provides expert advice for the development, qualification, and validation of analytical methods pertaining to biopharmaceutical analysis and CMC development used throughout the drug development and approval process under GxP guidelines. She also provides expert advice on establishing analytical biosimilarity for drug product using the 351(k) pathway, the generation of comparability plans and protocols, analytical method transfer, and SOP generation and compliance. She will also draft, review, author, and perform expert reviews of the Pharmaceutical Quality/CMC sections (Module 3) of the CTD for regulatory submissions.

Before COUR and BioTechLogic, Ashley was a research chemist in the Office of Testing and Research at the US FDA. While with the agency, she served as an expert in bioanalytical method development, qualification, and validation, specializing in mass spectrometry, chromatography, and spectroscopy. She has authored 20 peer-reviewed publications and is involved with several professional societies, including the American Society for Mass Spectrometry and CASSS. Prior to joining FDA, Ashley was a Chateaubriand Fellow of the Office of Science of Technology of the Embassy of France in the United States at École Polytechnique in Palaiseau, France. She has a BA in Chemistry from Pomona College in Claremont, California, and a PhD in Chemistry from the University of Arizona.

Brittany Oxendine-McConnell

Consultant

Brittany joined BioTechLogic in 2022 after positions at Neurogene and Novartis Gene Therapy Technologies. At Neurogene, she served in a quality and program support position. She worked as a bioprocess engineer for Novartis Gene Therapy, focusing on cell expansion and upstream processing, and was extensively involved in quality control sample management, compliance documentation review, and project management.

As a Technical Operations Consultant for BioTechLogic, Brittany provides project management and manufacturing support for clients with gene and cell therapy products, as well as consulting services in all areas of technical operations, including commercial drug substance and drug product manufacture, process development and validation, preparation of technical reports, batch records, SOPs, and other supporting documents. She will also conduct remediation projects to enhance compliance for manufacturing processes, including gap assessments, risk assessments for manufacturing processes regarding product quality/ stability/ aggregate generation, and implementation of corresponding corrective and preventive actions. Brittany has a BS in Biology from Meredith College and has numerous areas of training, including 21 CFR Part 11, clean room systems, clinical trial overview, and engineering design best practices.

Haleigh Wetzel

Consultant

Haleigh first joined BioTechLogic several years ago as an intern while completing her degree at the University of Rochester. She rejoined BioTechLogic after acquiring quality and process improvement, protocol management and development, quality control review, and project plan management experience through her positions with Astellas Pharmaceuticals, ECOG-ACRIN, and the TIMI Study Group. Haleigh has a BS in Neuroscience from the University of Rochester. She has also completed numerous training areas, including Collaborative Institutional Training Initiative (CITI) GCP course completion and certification in Clinical Trials with Investigational Drugs and Biologics. Additionally, she has completed Introduction to Biologic Drug Development and CMC Regulatory Parts 1 and 2.

As a Quality Assurance Consultant, Haleigh provides quality assurance and quality systems consultancy for start-up peptide and biologic companies as well as FDA remediation projects, implements and manages electronic Document Management System programs (e.g., ZenQMS and VEEVA), manages personnel training and onboarding, performs traditional document control functions, including SOP drafting, routing in eDMS, approval, and training, manages audits, including reports and observations, manages enrollment forms and ensures qualifications are complete, and manages clinical and nonclinical bioanalytical samples.

Samantha (Reilly) Burton

Senior Consultant

Samantha joined BioTechLogic in 2022 with over nine years of intensive experience in the startup biotechnology space. As part of the BioTechLogic team, Samantha will provide consulting services in drug substance and drug product process development, process optimization, remediation, and facility management. Her role includes preparing and reviewing qualifications, validations, risk assessments, gap assessments, batch records, and other technical documents. She will also support project management associated with contract manufacturing, process scale-up, technology transfer, and commercialization.

Previously, Samantha was a Senior Engineer / Program Manager at COUR Pharmaceuticals, where she was responsible for process design and management of new and existing drug product manufacturing. During her tenure at COUR, she coordinated translational activities of five therapies from R&D to GMP production and was the project lead for designing a large-scale pilot manufacturing facility. Prior to COUR, Samantha was a Product Development Engineer at a biotechnology company in Massachusetts, which develops innovative solutions for cell culture, tissue repair/regeneration, and offers biologic contract research and manufacturing services. In Massachusetts, Samantha led all cleanroom operations and process development efforts for emerging therapies and commercial products. She has an in-depth understanding of cleanroom design, design control, process validation, and Good Manufacturing Practices. Samantha received her B.S. in Chemical Engineering with a Biomolecular Concentration from the University of Notre Dame.

Alex Gibb

Director of Business Development

Alex first joined BioTechLogic in 2013 as a Senior Consultant in analytical sciences, having previously held technical positions at Novartis and Amgen. He left BioTechLogic to pursue an analytical position at CSL Seqirus before eventually transitioning his career toward business development at KBI Biopharma and Resilience.

In 2023, Alex returned to BioTechLogic as the Director of Business Development. He applies his analytical science experience and business development expertise to help biopharmaceutical developers, including gene and cell therapy organizations, advance their therapeutics to market faster.

He is dedicated to assisting biotechnology companies in transforming innovative and lifesaving therapies from ideas to marketable products through his expertise in life sciences, bioprocess development, and vaccine manufacturing. Alex has a BSc (Hons) in Biology from the University of East Anglia, Norwich, England.