Erik Kataisto

CURRENT: Director, Business Development, in Discovery, Pre-clinical and CMC spaces at Pharmaron supporting East Coast clients and ROW. Proven exponential growth track record with generation of $151MM in revenue within 5 years. PRIOR: Extensive experience (>20 years) in Process Research & Development and Manufacturing through the preparation of intermediates, API’s, controlled, and highly potent compounds in non-GMP and GMP environments on multi-kilogram to commercial scale. Developed and optimized syntheses of over 20 pharmaceutical API programs, performed tech transfers, and executed many from toxicology to Phase III clinical trials including registration and validation batches on 20-Liter to 2000-gallon scale, demonstrating a comprehensive understanding of engineering principles for the scale-up of unit operations from the bench to commercial scale. Authored and reviewed GMP documentation such as batch records, process validation protocols/reports, initiated change controls and deviations, completed root cause investigations, CAPA’s, and reviewed APR’s. Knowledgeable in scale-up of chemistry and unit operations, tech transfer, process validation, CMC process related activities, hazard assessments, calorimetry, statistical design of experiments (DoEs), QbD, Quality Systems, LEAN principles, continuous improvement, continuous processing, and cGMP’s. Experienced in cGMP small-scale API production (20-L) scale, pilot plant and highly potent API production (up to 500-gallon scale), and commercial manufacturing (up to 2000-gallon scale). Recently designed, developed, and implemented a small-scale cGMP suite for controlled substances manufacturing along with a new quality system. Works cross-functionally and possesses strong leadership, management of personnel, and project management skills. Has experience as a project manager and/or lead chemist for up to 3 concurrent projects while managing a scientific lab and personnel. Specialties: Process Development and Optimization, CMC related activities Technical Operations cGMP Manufacturing and Regulations Highly Potent Compounds Project Management Outsource CRO/CDMO Project Management Technology Transfer QbD and DoEs in process optimization Process Improvements and optimization of chemical processes Troubleshooting Critical Process Parameters (CPP's), PAR's and Critical Quality Attributes (CQA's) Batch Record Writing, PFD’s, Protocols, QMAS, IQ/OQ’s, and Validation Deviations, Change Controls, CAPA's Process Safety PAT tools and experienced in HPLC, NMR, GC, IR, DSC, TGA, DVS, and MS