Peter Davey Email & Phone Number

California, United States

San Carlos, California, Us

San Carlos, California, Us

San Carlos, California, Us

Essential Job Functions:- Managing a diverse team of scientists and engineers to deliver on key company goals- Overseeing 25+ million dollars of development and manufacturing work performed at international CDMOs- Authoring and reviewing IND sections- Determining which mission specific work should be performed in-house or outsourced to a CDMO based on project timeline, available resources and cost- Contribute to strategic decision making with senior leadership team- Develop multi-year budget projections and present to the EC to enable ultimate board approval- Troubleshoot manufacturing challenges with my international MSAT colleagues and my direct reports

San Carlos, California, Us

Essential Job Functions:- Managing a team in order to develop polysaccharide production processes suitable for manufacturing- Participating in weekly Sr. leadership meetings within the CMC team as well as the broader project team- Developing resourcing and hiring plans- Determining yearly CAPEX projections- Creating development plans utilizing project management tools- Determining whether to perform work packages in-house or to outsource to a partner CDMO - Managing CDMO partners Accomplishments:- Developed a completely standardized end-to-end manufacturing process for 24 polysaccharides that have unique chemical structures from Streptococcus pneumoniae serotypes to enable a first of its kind 24-valent pneumococcal conjugate vaccine- Developed a standardized fed-batch fermentation process that for 24 different S pneumoniae strains yielded between 400-1600 mg/L of polysaccharide and an average yield of >900 mg/L, generating a commercially viable and economically compelling upstream process within 15 months of initiating upstream development work- Led the development of a standardized downstream process that for 24 different pneumococcal polysaccharides yielded purified bulk between 85 and 780 mg of PS per L of lysate, with an average yield of >300 mg PS/L lysate, developing novel Intellectual Property to accomplish this industry first.- Championed the development a fast and robust SEC-RI method for PS concentration determination that replaced a complex and variable colorimetric anthrone assay, allowing the implementation of the time critical in-process control test for development and GMP batches.- Identified opportunity to remove five polysaccharide characterization assays (commonly found in compendial guidance documents) as these assays were outdated and are better replaced by modern NMR technology, saving the company more than $300K in out-of-pocket assay development and implementation costs and avoided even more expensive opportunity costs.

San Carlos, California, Us

- Served as the PS SME for developing a PS contract with a partner CMO to produce 24 cGMP polysaccharides as SutroVax does not have cGMP facilities, which enabled SutroVax to execute a $20+ Million polysaccharide development/manufacturing contract. *Assessed several CMOs ability to produce cGMP Streptococcus pneumoniae polysaccharides for SutroVax within the proposed timeline. *Concluded that one facility should produce all polysaccharides and selected the CMO that had the technical expertise and resources available to perform the development/manufacturing of Streptococcus pneumoniae PS. *Generated a fermentation development plan with the goal of developing a single fermentation process for all 24 serotypes. *Developed a PS purification development plan that focused on 5 serotype family leads based upon serotype specific physico-chemical characteristics- Devised a DOE-based experimental strategy evaluating feed medium composition and rate of addition using 6 model serotypes that led to the discovery of a serotype-independent fed-batch process that met or exceeded polysaccharide production targets for the first 6 serotypes, providing a solid foundation for a standardized fed-batch process applicable to all 24 serotypes.

Seattle, Wa, Us

Redmond, Washington, Us

- Completed international process development technical transfer package and training *Two-week training of International collaborators on DSP and Conjugation *Created and transferred Critical Process Parameters and SOPs- Developed fermentation and downstream processes for several polysaccharide based antigens * Streptococcal * Meningococcal * HIB * Pseudomonas- Lead on Scale-up of Downstream Processing from lab to pilot scale including; *sizing and purchasing scale-up equipment (TFF, HIC/IEX with Akta, depth filtration...) *Transferring process to GMP facility *Solving technical problems with scale-up *Maintaining or improving yield from lab to pilot scale *Introducing new IPQC testing to improve determination of process endpoints and overall process flow *Standardization of all DSP process steps- Designed and developed an Automated systems for DSP of Polysaccharide isolation *Constructing automated TFF, filtration and chromatography systems *Utilize electronic valves, pumps and sensors *Design of systems in Visio and AutoCAD *Currently employ signal transfer devices like Labjack, arduino, raspberry pi...to transfer signals from sensors to computers

Redmond, Washington, Us

- Bioproduct isolation utilizing many separations techniques including; Depth filtration, Tangential Flow Filtration, Column Chromatography by Akta Pilot and Chemical Methods. - In charge of developing timelines to complete the purification of our product and the management of time to stay on schedule. - Continuously improving our process of bioproduct isolation by reducing cost or improving yield.- Performed filter studies to determine optimal filter surface area necessary for scale up of filtration from lab to pilot scale. - Developed several colorimetric and HPLC based assays.- Participated in a 2 week training in CDAP conjugation chemistry with a world expert *Implemented techniques learned during training at Inventprise LLC - Developed fermentation infrastructure including assembly of bioreactor hardware, utility installation and programming the bioreactors to perform fed-batch fermentations.- Managed and completed the development of multiple streptococcus pneumoniae glycerol seeds.- Determined optimal growth conditions of bacterial strains through research and experimentation.- Performed the scale-up of fermentation from flask to 1L bioreactor to 19L bioreactor for production of a polysaccharide antigen. - Developed microbiological IPQC assays to determine sterility and viability of our bacteria.- Wrote many equipment, installation and experimental SOP's. - Experience working in a BSL-2 and cGMP environment.

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

-- Developed a novel technique utilizing ¹H NMR to quantify triacylglycerides (precursor to biodiesel) in live algal cells. -- Published a manuscript in Algal Research (link provided below) entitled, "Rapid Triacylglyceride Detection and Quantification in Live Micro-algal Cultures via Liquid State ¹H NMR.”-- Design and construction of an algae cell culturing device as a lost cost alternative to a photobioreactor.-- Collaborated in design of a flow cell for the improvement of a complex analytical instrument (NMR). * Flow cell allowed new functionality to NMR by allowing real time quantification of intracellular biomolecules. * Performed root cause analysis (RCA) for product improvement * Flow cell improvements conceptualized in autoCAD-- Ability to analyze biomolecules utilizing complex instrumentation such as NMR, GC-FID and GC-MS.-- Isolation of algal lipids by cell homogenization.and chloroform/methanol extraction.-- Separation of lipid and chlorophyll classes by silica column chromatography with solvents of increasing polarity. -- Cell culturing of multiple oleaginous organisms including microalgae, Cyanobacteria, E.Coli and yeasts. * Maintenance of independent cell lines on plates/ slants-- Isolation of DNA/RNA from microalgae and yeast.-- Quantification of DNA/RNA isolates by Nanodrop spectroscopy. -- Amplification of yeast and microalgae rDNA by PCR, utilizing gel electrophoresis and ethidium bromide staining for product visualization. -- Ability to follow SOP’s and developed SOP’s for NMR, sterile cell culture and anaerobic inoculation technique. -- Skilled in research project design with the desire to solve complex problems. -- Proven ability to analyze large data sets by writing visual basic application (VBA) programs and excel. -- Proficient in a wide variety of computer software including Microsoft Office Suite, AutoCAD, Photoshop, Adobe Reader, SigmalPlot and MATLAB

-- Developed teaching materials for a high school audience about advanced biofuel processes and technologies. -- Media Representative at Biomass Fuels Summit in Vancouver, WA October 2010 and Bio-Based Chemicals Summit in San Diego, CA February 2010* Represented Advanced Biofuels USA at these conferences while discussing bioproducts with industry leaders, business representatives, scientists and engineers-- Wrote two articles summarizing the conferences which were later published on the advanced biofuels website (link in the projects panel)

Olympia, Wa, Us

-- Assisted in experiments to infect E. coli and P. aeruginosa with bacteriophage under anaerobic and aerobic conditions.-- Learned aseptic technique through handling of bacteriophage stock cultures. -- Development of numerous microbiological skills including making media/plates, streak plating, titering, culture maintenance and pulsed field gel electrophoresis. -- Created anaerobic and sterilization technique protocols for future bacteriophage technicians.

Master Of Science (M.S.), Biological Systems Engineering

Bachelor Of Science (B.S.), Biochemistry And Molecular Biology

Education record