Ariel Bornstein

Ariel comes to BioTechLogic with over 20 years in the biotech industry, bringing experience in process development, early phase & commercial manufacturing execution and oversight, quality systems, training, and remediation of production operations and quality systems.

At BioTechLogic, Ariel has supported clients with a broad range of products across all stages of development, specializing in CMC projects and cross-functional activities involving MSAT, production, and quality units. Prior to joining BioTechLogic, Ariel most recently served as a Process Development Senior Scientist in the plasma products industry at Biotest (now ADMA Biologics). In addition to developing and executing bench- and pilot-scale development & manufacturing support studies, as well as providing real-time technical support for fractionation and purification operations, Ariel served as the lead investigator for product-related deviations and the lead change control and CAPA author for technical issues. Ariel was also responsible for the sourcing, technical assessment, and implementation of a new, automated, commercial fill line and the associated container closure system components.

Prior to bringing the filling operations in-house, Ariel was responsible for technical oversight of contract filling operations. Ariel’s team also executed a complete material compatibility and extractables & leachables assessment for all product-contact materials at the site. Before joining Biotest, Ariel served in a variety of production roles at Genzyme, now Sanofi, as part of the Protein Purification department.  During his decade-long career at Genzyme, Ariel worked in the management and execution of production operations, deviation investigation authoring & review, change control and CAPA authoring & review, technical writing, and continuous improvement. Ariel also served as part of the Consent Decree remediation team where he developed a comprehensive On-The-Job Training program for his department and conducted a complete overhaul of all department SOPs and batch records to improve quality compliance and reduce batch production & review cycle times.

• Phase-appropriate procedural development, study authoring, and quality remediation for production operations
• Technical support and person-in-plant for clinical and commercial manufacturing
• Authoring, review, and remediation of quality systems (deviation, CAPA, change control)
• CMC regulatory filing document authoring for global regulatory bodies
• Regulatory audit preparation and real-time support

• Working knowledge of Hebrew and Spanish
• Speaker for local, regional, and national freshwater fishkeeping societies on the topics of aquarium husbandry and ichthyological exploration.
• Bornstein, A. 2001. Biotoecus opercularis. Journal of the American Cichlid Association 204:1-9
• Bornstein, A. 2015. Über die zufällige Nachzucht von Pseudochalceus kyburzi Schultz, 1966. Amazonas Magazin Natur und Tier Verlag. July.
• Edited English-language edition of Lamboj, A., 2004. The Cichlid Fishes of Western Africa. Birgit Schmettkamp Verlag, Bornheim, 255p.
• Editor, Cichlid News Magazine (2005-2007)

Biotest/ADMA Biologics:
Senior Scientist, Process Development and MSAT

Genzyme/Sanofi:
Suite Coordinator
Manufacturing Specialist, Protein Purification
Senior Manufacturing Associate, Protein Purification

Brandeis University
B.A. in Anthropology
Environmental Studies Program