Ryan Soderquist Email & Phone Number

Lawrence Township, NJ, US

• Establishing first-time CMC strategies and workflows for an AAV gene therapy asset
• Advancing CMC strategies and deliverables for cell modification and DNA inhibitor products
• Driving conversion of a commercial cell therapy product from an adherent to a suspension LVV manufacturing platform
• Leading CMC team through a global submission package for label expansion of a commercial cell therapy product

• Directed development and commercialization teams (i.e. CMC team lead across DS, DP, Analytical, Regulatory, Marketing & Supply Chain) for two high-priority pipeline monoclonal antibody assets
• Drove advancement of a single-use and continuous process (from a fed-batch process) for a commercial product

• Rapidly built a team of skilled upstream and downstream scientists (from 20 to 60 staff over a 12-month period)
• Directed an accelerated cross-site process change for a commercial product to recover > $125 MM revenue annually
• Led late-stage drug substance and drug product efforts and facilitated CDMO selection for an oncolytic virus asset

Thousand Oaks, CA, US

• Directed cross-site process development efforts to advance a novel oncology asset under accelerated timelines
• Led groups implementing new technologies for continuous downstream and upstream processing, including AMBR and Tecan platforms with custom capabilities, to enable next generation processing paradigms
• Managed and developed a team of six direct reports with responsibilities for commercial process development, process characterization and progressive manufacturing advancement for novel pipeline molecules
• Facilitated development of a bioreactor-based process to replace roller bottle processing for a commercial product

Thousand Oaks, CA, US

• Managed and developed seven direct reports and a graduate intern with multiple interdisciplinary backgrounds
• Directed external CMO activities for upstream and downstream commercial process development, process characterization, tech. transfer and scale-up as process team lead for a biosimilar mAb and an innovator mAb
• Led efforts to relocate purification laboratories from Washington and Colorado to Cambridge, MA, and served as a change agent for staff movements into next generation office (a.k.a. open office) and laboratory.

Thousand Oaks, CA, US

• Managed and developed four direct reports, who were responsible for various aspects of filtration, chromatography and viral clearance evaluations in a matrixed project and late stage process development setting
• Authored and approved process characterization reports and regulatory filing sections under critical timelines as the downstream process characterization lead for Amgen’s first biosimilar molecule (FDA approved in Sep..
• Championed efforts to find innovative approaches for the enrichment and isolation of host cell proteins and DNA to enable network-wide implementation of advanced process challenge studies and impurity characterization

Thousand Oaks, CA, US

• Managed a multi-disciplinary group of four direct reports and one indirect report in a regulated environment
• Developed and implemented complex particle characterization methods for protein-silicone oil complexes, and procured state-of-the-art technology for the detection and quantification of protein particulates and aggregates
• Led cross-site efforts to evaluate and demonstrate comparability and stability with respect to particle attributes for drug substance and drug product manufacturing site transfers and the introduction of new delivery.
• Developed and led strategies for in-line and at-line process analytical technology in commercial processes and implemented complex biochemical characterization methods for monoclonal antibodies and attenuated viruses
• Completed Six Sigma Black Belt and Lean-DFSS certifications through Amgen and the Aveta business institute

• Led authoring of BLA sections for new virus-like particle purification and adjuvant manufacturing facilities
• Developed small scale purification models for all downstream unit operations of a key therapeutic protein asset

Boulder, Colorado, US

• Advanced gene therapy administration in the central nervous system by microparticle encapsulation of plasmid DNA and polymer-protein bioconjugation (PEGylation) strategies for enhanced spinal delivery and distribution
• Developed in vitro bioassays, conducted institutionally approved in vivo animal testing, and assessed in vivo drug distribution profiles with immunohistochemistry and confocal fluorescence microscopy
• Conducted RT-PCR, ELISA, Western Blotting, Mass Spec and HPLC for in vitro and in vivo sample analysis

Thousand Oaks, CA, US

• Developed a new Micro-Flow Imaging (MFI) method and technology for sub-visible particle characterization
• Prepared technical communications and trained personnel from other corporate sites in new methodologies
• Completed a peer-reviewed method development report for multi-site method incorporation

Pullman/Spokane/Tri-Cities/Vancouver/Everett/Global, Washington, US

• Developed methods to enhance recombinant protein production from transgenic plant cells
• Maintained sensitive plant cell suspensions, quantified antibody titers by ELISA, performed restriction enzyme analysis, PCR amplification, site-directed mutagenesis, and gel electrophoresis
• Completed extensive hands-on protein biotechnology training through interdisciplinary laboratory rotations in chemical engineering, biochemistry and molecular biology laboratories* Completed extensive hands-on protein.

Logan, Utah, US

• Conducted pilot-scale 10 and 100 L fermentations and harvests for external clients
• Optimized tangential flow filtration and FPLC methods for advanced protein purification protocols
• Developed training protocols in Fermentation, Microbial Scale-up and Protein Purification for industrial clients

Logan, Utah, US

* Designed and built a nutrient-mist bioreactor for the cultivation of plant organ cultures* Developed and implemented tissue culture protocols for Ginkgo Biloba explants* Organized materials for academic and research purposes

Doctor Of Philosophy - Phd, Chemical Engineering

Ms, Chemical Engineering

Bs, Biological Engineering