Rachel Houp

Rachel has had an extensive career in the biopharmaceutical industry, with a background in cell culture manufacturing, process validation, quality assurance, regulatory affairs, and molecular biology testing. She joined BioTechLogic in 2004, providing technical, quality, and regulatory support to clients with gene therapy, cell therapy, vaccine, protein, oligonucleotide, and synthetic blood products.

Rachel integrates into the project team to fully understand the needs for each project and to ensure timelines are met. As part of the BioTechLogic team, Rachel’s responsibilities include the preparation of CMC regulatory submissions for all phases of development, process development reports, process comparability documentation, technology transfer documentation, process validation and support validation documentation, and combination product design control documentation. She has served as person-in-plant for technology transfers, development batches, and process validation execution. Rachel also performs quality and compliance audits, batch record reviews, and facility and process gap assessments.

Prior to joining BioTechLogic, Rachel held positions in quality assurance, validation, small scale cell culture manufacturing and Quality Control testing at Human Genome Sciences (GSK), Diosynth/Akzo Nobel/Covance Biotechnology Services (FUJIFILM Diosynth Biotechnologies), BioReliance (Millipore Sigma), and Tektagen (Charles River Laboratories). Rachel holds a B.S in Biology, with a concentration in Molecular Biology and Biotechnology from East Carolina University.

As part of the BTL team, Rachel provides API and DP manufacturing and project support for clients with gene and cell therapy, vaccine, protein, oligonucleotide, and synthetic blood products. Typical client asks are for CMC technical and regulatory support for gene and cell therapies, biologics, and synthetic blood products—including but not limited to Stage 1 and Stage 2 process validation activities, inspection readiness preparation, qualification audits, an regulatory submission writing.

Rachel’s 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.

East Carolina University
B.S. in Biology, with a concentration in Molecular Biology and Biotechnology