Biochemical engineer and leader with extensive experience in upstream and downstream protein production for research, pre-clinical and cGMP production applications. Experienced team manager and project leader, motivated to bring drug candidates and products to the clinic and market and to optimize commercial processes.Specialties: GMP biologics manufacturing and recombinant protein expression. Fermentation and cell culture production with multiple expression systems. Process development and downstream unit operations. Cell line and media development. Process technical transfer, CMO and outsourcing coordination. Regulatory support (inspections, CMC for BLA and IND, HA responses), process validation, project management, documentation and presentation skills.
Listed skills include Gmp, Technology Transfer, Cell Culture, Biotechnology, and 31 others.