Jacob Staudhammer

PRINCIPAL

Bioengineer with deep expertise in viral vector process development, validation, and analytics.

About Jacob

Jacob joined Dark Horse Consulting in January of 2021, bringing expertise and training in Viral Vectors, Biochemical Engineering, and Molecular Biology. Jacob’s prior work in industry focused on process and analytical development of gene therapy viral vectors, spanning from pre-clinical development through clinical manufacturing and process validation for over 7 clinical-stage programs.

Jacob held increasing roles at Adverum Biotechnologies in Process Development, focusing primarily on Upstream and Downstream development of an SF9-Baculovirus AAV process. While in these roles, Jacob also developed several novel methods for advanced AAV analytics using Next-generation Sequencing which led to the invention of a patent-pending analytical method.

While at Orchard Therapeutics, Jacob focused on the Process Validation and Process Characterization of late-phase Lentiviral Vectors (LVV) for Orchard’s rare disease portfolio. He oversaw the Process Characterization and PPQ strategy of a late-phase program using a Quality-by-Design approach, resulting in an effective PPQ strategy. Jacob authored and oversaw multiple Process Characterization protocols, reports, and assessments to develop a Process Control Strategy. In addition to these responsibilities, Jacob supported external LVV manufacturing activities including root cause analyses and serving as person-in-plant for multiple manufacturing batches.

During his time at CODA Biotherapeutics, Jacob led the Process Development team focused on the scale-up and development of a suspension AAV process and developed partnerships with CDMOs for AAV manufacturing.

Jacob holds a Six Sigma Green Belt certification, and has completed certificates from ISPE in Process Validation, and ASQ in Design of Experiments.

EXAMPLES OF RECENT WORK

  • Established in-process and release specifications using statistical analysis methods in JMP
  • Authored and oversaw the execution of PPQ protocols and reports
  • Used DOE methodologies to design and execute multiple process characterization studies
  • Conducted CDMO audits and served as person-in-plant during cGMP manufacturing campaigns
  • Designed and implemented multiple novel AAV and LVV analytical methods

PAST EXPERIENCE

CODA Biotherapeutics
Senior Process Development Engineer

Orchard Therapeutics
Senior Engineer, Process Validation

Adverum Biotechnologies
Engineer II, Process Development

CERTIFICATIONS

  • Process Validation (ISPE)
  • Design of Experiments (ASQ)
  • Six Sigma Green Belt

EDUCATION

Oregon State University
B.S. in Bioengineering (cum laude) with minors in Mathematics and Bioenergy

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