Blake Bergam

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

Blake’s client projects most frequently consist of initiation of GMP manufacturing, process instrument and single use systems development, CMC regulatory authorship of briefing books, INDs and BLAs, and deep dives into raw material suitability risk assessments.

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.

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 the 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. Achieving his Pharmaceutical GMP Professional certification gave him an in-depth understanding of the global regulations and requirements for all things GMP.

• Tech transfer into GMP manufacturing
• Tech Ops at CDMOs
• CMC regulatory authorship
• Quality systems investigations
• Process & technology development
• Project management

• Bergam B, Mills, S. (2024) Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy" Cell and Gene. May 24: Guest Column

• Certified Pharmaceutical GMP Professional (ASQ-CPGP)
• Certified Six Sigma Green Belt (ASQ-CSSGB)
• Lean Specialized Credential (ASQ)

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

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