Kaela Siahpush

Kaela Siahpush is a detail oriented problem solver and specialist with 7 years of experience in biologics, and cell therapies, developing protein therapeutics, cell culture processes and technology transfers and associated regulatory filings. She has led several projects on process development and optimization, as well as process control strategy, technology transfer in start-up and major biotechnology company settings. Her experience includes designing and implementing methods, improving efficiency, yield and throughput, and product quality.  Prior to consulting Kaela tested new technologies for improving CAR-T cell therapy processes at Bristol Myers Squibb.

Kaela is adept at leading technical initiatives, conducting risk assessments, and authoring a broad range of technical and regulatory documents, including IND submissions, control strategies, batch records, and SOPs, ensuring compliance with FDA, EMA, and ICH guidelines. She holds a Lean Six Sigma Yellow Belt certification and is proficient in tools such as Veeva Vault, JMP, Excel and Prism.

Kaela earned her Bachelor of Science in Chemical & Biological Engineering from the University of Colorado, Boulder.