Blake Bergam

CONSULTANT

Bioengineer since 2015, specializing in cell therapy process and technology development, tech transfer and GMP operations. Lean Six Sigma Green Belt.

About Blake

Blake joined Dark Horse Consulting in 2021, bringing expertise in gene-modified cell therapy process, technology and device development, technology transfer and GMP operations.

Blake’s career began in 2015 at Seattle Genetics where he was responsible for maintenance of equipment and systems supporting Research, QC and GxP labs. His responsibilities included execution of bioburden assays, authoring SOPs and ensuring GDP compliance regarding the controlled document storage room.

Blake joined Juno Therapeutics in 2016 in the Quality Assurance Operations department during the startup of Juno’s GMP cell therapy manufacturing facility. His oversight of cGMP operations included leukapheresis receipt, raw material and patient lot disposition, batch record review, deviation investigations, SOP and batch record revisions, and training.

From 2017 to 2021 Blake held increasing roles in the Process Sciences and Technologies department while developing manufacturing scale cell purification and washing technologies. These lab activities involved single use system, hardware and automation development and characterization. He also lead process development and technology transfer of CAR-T cell therapies for initiation of a phase I clinical trial. Blake’s Six Sigma Green Belt enables him to facilitate root cause analysis, failure mode and effects analysis, and continuous improvement initiatives.

PAST EXPERIENCE

Bristol Myers Squibb (Formerly Juno Therapeutics, Inc.)
Associate Process Engineer – Process Engineer II, Process Sciences & Technologies
Associate II-III, Quality Assurance Operations

Seattle Genetics, Inc.
Laboratory Technician, cGMP Facilities

CERTIFICATIONS

Six Sigma Green Belt.

EDUCATION

Syracuse University
B.S. in Bioengineering, Minor in Biology

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