Member of site leadership team for the Pelican Expression Technology™ business unit. Provide scientific oversight and input for business growth strategy, innovation, technical assessment and product development opportunities. Responsible for R&D downstream processing, analytical development and technology transfer for protein therapeutics.

Accountable for analytical strategy and CMC development for lead identification, clinical advancement and commercialization of Pfenex product candidates. Additional scope included portfolio strategy, biological target identification, technology diligence and external collaborations/CRO oversight. Provided oversight to team on global regulatory guidance’s that impact analytical method validation approaches for CMC regulatory filings (IND, NDA, BLA).

Lead and provide broad analytical sciences insights and strategy to product development teams enabling the advancement and ultimate commercialization of Pfenex's protein therapeutics. Provide leadership in shaping regulatory data packages for establishing analytical comparability, similarity and protein characterization approaches. Provided oversight of multiple CRO's for product characterization, release, and stability. Monitored and educated the team on global regulatory guidance’s that will impact analytical approaches for establishing biosimilarity. Established comprehensive technical strategy for achieving fingerprint-like similarity for each of Pfenex biosimilar candidates.

Responsible for technical leadership, capability strategy, and resource deployment for analytical sciences and downstream processing disciplines; accountable for performance management of direct reports:-Formed, organized, and led new functional R&D functions within the company -Implemented systematic approach and protocols for HTP resin screening, method scouting and chromatography optimization to expedite downstream development from bench to pilot scale-Led multiple analytical characterization studies to demonstrate analytical comparability of proteins produced in Pseudomonas fluorescens vs. alternative expression systems (e.g., E. coli) that helped solidify commercial relationships, reduce regulatory concerns and expand business opportunities-Developed highly-automated analytical sample preparation systems coupled to high-throughput parallel analysis to expedite Pfēnex Expression Technology, host strain selection, fermentation optimization, and downstream process development -Expertise in all aspects of protein downstream process development including clarification, precipitation, extraction, microfiltration, diafiltration, preparative chromatography, and scale-up-Experience leading teams to purify and characterized multiple types of proteins for internal projects and client evaluations (e.g., enzymes, growth factors, cytokines, toxins, vaccine antigens, single domain antibodies, scFvs, Fabs, Mabs)-Support business development by meeting with prospective clients -Certified Green Belt in Six Sigma methodology; Site Chemical Hygiene Officer

Broad scope of responsibility including directing teams responsible for downstream bioprocess development and analytical support for contract-based microbial production of biopharmaceutical proteins:-Key technical team member involved in commercializing Pfēnex Expression Technology, a bacterial recombinant protein expression system-Developed and implemented detailed protein bioanalytical characterization methods to detect process impurities/contaminants, protein isoforms, protein microheterogeneity-Worked independently and as part of team with clients to meet aggressive timelines and milestones -Demonstrated track record of influencing without direct reporting relationship

Responsibilities included R&D technical leadership and support for Dow’s Human Health and Diagnostics platform; worked closely with commercial project leaders to develop strategies for new business opportunities and value capture; intellectual property creation and strategy; biochemistry and analytical support for multi-disciplinary teams: -Key role in building analytical and other biotechnology capabilities at Dow San Diego site-Developed and patented an enzyme-based electrochemical diagnostic device for use in the weight-loss and diabetes markets. Technology licensed to an external company.Developed and patented a polyurethane hydrogel surface modification technology for immobilizing and stabilizing biomolecules in protein microarray and diagnostic applications -Demonstrated hands-on application of electrospray mass spectrometry, tandem mass spectrometry, electrochemistry, multiple types of HPLC separations and modes of detection, sample prep, GC-FID, GC-MS-Analytical Sciences Teamwork Award 2003 [The Development of a Breath Acetone Biosensor]