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About Our Staff

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 over 10 years of experience in the biopharmaceutical industry. He has held 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 Trajkoski has over 9 years of experience in the biopharmaceutical industry. 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 API and Drug Product manufacturing, analytical technology development, and preparation of CMC regulatory submissions. As part of the BioTechLogic team, Julie provides project management and manufacturing support for clients with protein, oligonucleotide and synthetic blood products. Responsibilities include project management of the API and Drug Product contract sites, process scale-up, process validation, regulatory submission packages, and global regulatory inspection readiness. Over the years, Julie's role has also expanded to prepare CMC regulatory documentation for IND/IMPD/CTX/BLA/MAA submissions in CTD format. She holds a B.S. in Chemical Engineering from Northwestern University.

Mike Rooney, PhD has over 7 years of experience in the biopharmaceutical industry with Diosynth (Akzo Nobel) and Millipore where he managed analytical method development, qualification, validation and GMP testing to support products ranging from phase II to commercial. As part of the BioTechLogic team, Mike has provided Analytical support for clients with protein, oligonucleotide and synthetic blood products. Mike has a breadth of experience covering all aspects of QC and analytical testing, ranging from standard methodologies to bioanalytical PK/Ab/Potency procedures to Microbiological procedures, While at BioTechLogic, Mike has assisted previous and current clients in the following areas: design of validation/qualification strategy; writing validation/qualification protocols and reports; review of internal reports to identify gaps in ICH and regulatory compliance; guidance on method requirements and capabilities, with an eye toward developing methods that can withstand the rigors of GMP testing to support a commercial product; technology transfer; management of third party CRO and CMO testing laboratories, preparation of CMC regulatory documentation for IND/BLA/MAA submissions; and performing QC and laboratory audits. Mike holds a B.S. in Chemistry from the University of Richmond and a Ph.D. in Chemistry from the University of North Carolina.

Becky McCuen has over 11 years of experience in the biopharmaceutical industry and has held positions at Diosynth RTP (AKZO Nobel), Covance Biotechnology Services and Apex Biosciences. She has served in capacities that supported recombinant protein process development, manufacturing and validation, including management of Process and Cleaning Validation activities in a multi-product contract manufacturing environment. As part of the BioTechLogic team, Becky provides project management and manufacturing support for clients with development and commercial products and processes. Her responsibilities include on- and off-site management of the API and Drug Product manufacturing sites, process scale-up and transfer, and process and cleaning validation. Additionally, she supports facility, process and QA compliance initiatives and preparation of regulatory submissions. She holds a B.S. in Chemical Engineering from North Carolina State University.

Rachel Houp has over 12 years of experience in the biopharmaceutical industry. 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, oligonucleotide and synthetic blood products. Her responsibilities consist of validation (including support validations), quality assurance and project management support. Rachel has also gained experience in the preparation of CMC regulatory documentation including IND, IMPD, BLA and MAA submissions in the CTD format. Rachel holds a B.S in Biology, with a concentration in Molecular Biology and Biotechnology from East Carolina University.

Kurtis Epp has over nine years of experience in the biopharmaceutical industry. He has held development and manufacturing positions at G.D. Searle, Pharmacia, and Pfizer and has been a manufacturing manager with BioTechLogic since 2004. His experience includes API manufacturing, technology relocation, production scale-up, process validation, and product supply chain management at internal and third-party manufacturing sites both domestically and internationally. He holds a B.A. in Biology from Cedarville University.

Adeana Dorsey has over 10 years of experience in the pharmaceutical, medical device, biopharmaceutical, and combination product industries. She is the founder of AMD Consulting, formerly the Associate Director of Quality Assurance at BioMimetic Therapeutics, Inc., held several positions in regulatory at Synthon Pharmaceuticals, and was responsible for quality assurance activities at Diosynth (Akzo Nobel). As part of the BioTechLogic team, Adeana provides quality assurance, regulatory, and project management support, including but not limited to, the development of Quality Management Systems, quality planning and continuous improvements, on and off-site process and analytical validation QA support, supplier assessments, internal and external audits, and global inspection readiness. In addition, she is responsible for providing regulatory strategy, guidance on regulatory requirements, and for preparing CMC regulatory documentation for IND, NDA, BLA, MAA, PMA, and Design Dossier submissions. Adeana is a certified ISO 9001 Lead Auditor, maintains her Regulatory Affairs Certification (RAC), and is a Certified Six Sigma Green Belt (CSSGB). Adeana is a member of RAPS, PDA, the Combination Products Coalition, and ASQ. She holds a B.S. in Biology from Marshall University.

John Kandl has over 10 years of experience in the biopharmaceutical industry. He has recently 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.