I love to travel and learn about international customs and cultures I enjoy hiking, mountaineering, soccer and a good walk spoiled ie golf
Peter Davey
Foster City,CA
Summary
Dynamic leader with 12+ years (11+ in PCV) of biotech industry experience building exceptional teams (30+ members), delivering projects on-time, spearheading initiatives, mitigating risks, managing resources and extreme complexity. Responsible for leading the successful development and manufacturing of 31 polysaccharide serotypes starting from licensing the bacterial strains through commercial manufacturing over an 8 year period, >200 manufacturing lots, >90 cell banks and managing >$130MM in contracts. Proven track record of leading international teams that have developed novel processes for fermentation and purification of antigens to support production of Pneumococcal conjugate and Group A Streptococcus vaccines.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Executive Director PS PD and Clinical MFG
Vaxcyte Inc
01.2024 - Current
- My team grew to 30+ team members in the past three years which can lead to changes in team culture and requires improved systems, I worked with my team to screen new team members for our core team values and discussed with my direct reports how they can reinforce these values with their direct reports as well as developed systems of team governance, meeting structures, timeline and resource management, which has resulted in a high-functioning team that has been able to tackle one of the most complicated process characterization development programs in the history of the industry on a tight timeline while successfully managing continuous manufacturing campaigns.
- Defined a novel approach to process characterization for 31 unique pneumococcal polysaccharides with more than 10 unit operations by selecting a subset of serotypes to study based on a matrix of serotype physicochemical, quality and performance attributes, reducing the time and cost to perform these studies from multiple years and tens of millions of dollars to less than a year and a few million dollars.
- Preparing for performance qualification lots on 31 unique polysaccharides for the first time at a small biotechnology company in co-ordination with an international CDMO is both complex and challenging. I recognized that this effort requires significant cross-functional expertise and repeatedly presented at internal PPQ and CMC team meetings to gain expert feedback and alignment on key decisions. In addition, I started an internal polysaccharide PPQ meeting and Vaxcyte/CDMO external colleague stage-gate meetings which enabled cross-functional collaboration, inter-company strategic alignment and tactical execution that led to a Q3 2025 PPQ campaign initiation.
- The purified polysaccharide demands of the VAX-31 product required multiple years of continuous manufacturing and >100 batches to be produced which demands significant resources to provide sufficient MFG oversight. To improve our workload allocation, the PS PD team trained, collaborated with and empowered Vaxcyte’s newly formed site MSAT team to support ongoing MFG oversight including PIP, document review and troubleshooting which has led to the successful production and release of these required batches.
- It is challenging to align with an international CDMO on late-stage documentation approaches, I identified key stake holders at our CDMO and worked with them to understand their processes and SOPs, which led to successful completion of a Vaxcyte/CDMO PC study agreement, pre/post PC FMEAs, PRAs and RA2s allowing for a Q3 2025 PPQ start.
Senior Director PS PD and Clinical MFG
Vaxcyte Inc.
07.2022 - 01.2024
- Vaxcyte’s preferred CDMO did not have the capacity to accommodate Vaxcyte’s Group A Streptococcus vaccine program, I drove the selection process for a new CDMO by contacting and assessing several international CDMOs based on facility/technical capability, cost, suite availability and GMP readiness, which led to the selection of a top rated CDMO that delivered on cell banking, component engineering and GMP campaigns for PS, protein and DS components of Vaxcyte’s vaccine.
- Optimized a carbon filtration unit operation that caused 1 of 31 pneumococcal polysaccharides produced using a platform manufacturing process to be low-yielding, increasing yield 4-fold and saving Vaxcyte an amount projected to exceed $100 M over ten years.
- I determined that the PS in-process assays were not sufficiently developed for process characterization and the analytical team did not have the bandwidth to support development and analysis of in-process PS pools, I met with our head of CMC and analytical development and we determined that the PS team should build an analytical team while maintaining close connection with the AD team, which led to the successful development of a PS AD team implementation/development of over 11 PS in-process assays.
- Created a timeline/activities map using Asana software that enabled resource planning for my department, thereby increasing laboratory personnel efficiency that in turn facilitated team member cross-training that further increased laboratory resiliency and productivity.
- Devised a strategy in coordination with Environmental Health and Safety (EH&S) team to ensure that lab personnel working with new strains of a BSL2 organism for which there was not a commercially available vaccine had access to antibiotics at a nearby clinic in the event of accidental exposure, reducing company liability and earning team members’ gratitude.
Director PS PD and Clinical MFG
Vaxcyte Inc.
01.2021 - 07.2022
- Vaxcyte’s preferred CDMO is based in Germanic Switzerland which created both temporal and cultural challenges between organizations, I moved to Switzerland for 2 years as a PS SME, learned German to an A2 level and studied Swiss history and culture, which led to us developing a collaborative team and a completely standardized end-to-end manufacturing process for 31 unique Streptococcus pneumoniae polysaccharides to enable a first of its kind 31-valent pneumococcal conjugate vaccine.
- Developed a standardized fed-batch fermentation process that for 31 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 31 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.
- Led the development of novel processes for cell banking which enabled the production of 31 research cell banks, 31 master cell banks and 31 working cell banks.
Associate Director, PS PD and Clinical MFG
Vaxcyte Inc.
01.2018 - 03.2021
- Developed a standardized fed-batch fermentation process that for 31 different pneumococcal 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 31 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.
- Led the development of novel processes for cell banking which enabled the production of 31 research cell banks, 31 master cell banks and 31 working cell banks.
Group Leader, Polysaccharide PD
SutroVax, Inc
05.2017 - 01.2018
Process Development Engineer
Juno Therapeutics Inc
10.2016 - 05.2017
Process Engineer
Inventprise LLC
06.2013 - 09.2016
- Managed the production and transfer of Pneumococcal MCB and WCBs to international partners
- Completed technical transfer package and lead two trainings on Pneumococcal Conjugate Vaccine (PCV) Fermentation and Downstream Processing
- Led Pseudomonas aeruginosa contract vaccine development project
- Designed and constructed automated systems for antigen purification which was funded by and eventually demonstrated to Bill Gates
Graduate Research Associate
Bioprocessing and Bioproducts Engineering Laboratory, WSU
01.2010 - 01.2012
- Designed and constructed flow cell for an NMR instrument to allow continuous analysis of lipids during an active fermentation
Research Assistant
The Bacteriophage Laboratory, The Evergreen State College
01.2009 - 01.2010
Education
Master of Science Degree - Biological and Agricultural Engineering
Washington State University
Pullman, WA08.2012
Bachelor of Science Degree - Biochemistry
Colorado State University
Fort Collins, CO12.2008
Skills
Cell banking
Fermentation
Purification
Process design
Scale-up/down
Technology transfer
Manufacturing strategy development
Pilot plant establishment
Process characterization
Assay development
Process validation
International collaboration
Resource allocation
Leading teams
Certification
• Certificate of Appreciation award at bioprocessing and bioproducts engineering laboratory, 2012
• CDAP Chemistry training completion with Andrew Lees, 2012
• Design of Experiments Certificate of Completion, 2020
• Vaxcyte Biosafety Officer, 2020
• Certificate of Attendance, Process Validation for Biotechnological Products US Masterclass, 2022
• Legacy Award Vaxcyte Inc, 2024
- Certified Project Management Professional (PMP), Estimated Q1 2026
Interests
Timeline
Executive Director PS PD and Clinical MFG
Vaxcyte Inc
01.2024 - Current
Senior Director PS PD and Clinical MFG
Vaxcyte Inc.
07.2022 - 01.2024
Director PS PD and Clinical MFG
Vaxcyte Inc.
01.2021 - 07.2022
Associate Director, PS PD and Clinical MFG
Vaxcyte Inc.
01.2018 - 03.2021
Group Leader, Polysaccharide PD
SutroVax, Inc
05.2017 - 01.2018
Process Development Engineer
Juno Therapeutics Inc
10.2016 - 05.2017
Process Engineer
Inventprise LLC
06.2013 - 09.2016
Graduate Research Associate
Bioprocessing and Bioproducts Engineering Laboratory, WSU
01.2010 - 01.2012
Research Assistant
The Bacteriophage Laboratory, The Evergreen State College
01.2009 - 01.2010
Bachelor of Science Degree - Biochemistry
Colorado State University
Master of Science Degree - Biological and Agricultural Engineering
Washington State University
Awards, Patents and Publications
Certificate of Appreciation award at bioprocessing and bioproducts engineering laboratory, 2012,
CDAP Chemistry training certificate of completion with Andrew Lees, 2012,
Design of Experiments Certificate of Completion, 2020,
Vaxcyte Biosafety Officer, 2020,
Certificate of Attendance, Process Validation for Biotechnological Products US Masterclass, 2022,
Legacy Award Vaxcyte Inc, 2024,
Publications and Patents
• Yu J, Ravenscroft N, Davey P, Liyanage R, Lorenz O, Kuttel MM, Lo SW, Ganaie FA, Nahm MH. New pneumococcal serotype 20C is a WciG O-acetyltransferase deficient variant of canonical serotype 20B. Microbiol Spectr. 2025 Jan 7;13(1):e0244324. doi: 10.1128/spectrum.02443-24. Epub 2024 Nov 29. PMID: 39612217; PMCID: PMC11705870.
• Non-Native Amino Acid Click Chemistry-Based Technology for Site-Specific Polysaccharide Conjugation to a Bacterial Protein Serving as Both Carrier and Vaccine Antigen, Neeraj Kapoor, Satoshi Uchiyama, Lucy Pill, Leslie Bautista, Angie Sedra, Lu Yin, Maritoni Regan, Ellen Chu, Taylor Rabara, Melissa Wong, Peter Davey, Jeff Fairman, and Victor Nizet, ACS Omega 2022 7 (28), 24111-24120, DOI: 10.1021/acsomega.1c07360
• Jeff Fairman, Paresh Agarwal, Sandrine Barbanel, Christopher Behrens, Aym Berges, John Burky, Peter Davey, Phil Fernsten, Chris Grainger, Sherry Guo, Sam Iki, Mark Iverson, Martin Kane, Neeraj Kapoor, Olivier Marcq, Thi-Sau Migone, Paul Sauer, James Wassil,
• Non-clinical immunological comparison of a Next-Generation 24-valent pneumococcal conjugate vaccine (VAX-24) using site-specific carrier protein conjugation to the current standard of care (PCV13 and PPV23), Vaccine, Volume 39, Issue 23, 2021, Pages 3197-3206, ISSN 0264-410X, https://doi.org/10.1016/j.vaccine.2021.03.070.
• Peter T. Davey, William C. Hiscox, Ben F. Lucker, James V. O'Fallon, Shulin Chen, Gregory L. Helms, Rapid triacylglyceride detection and quantification in live micro-algal cultures via liquid state 1H NMR, Algal Research,Volume 1, Issue 2,2012,Pages 166-175, ISSN 2211-9264
• PCT/US2022/016630, PURIFICATION PROCESSES FOR POLYSACCHARIDES AND POLYPEPTIDE CONJUGATES THEREOF
• PCT/US2023/63457632, PURIFICATION OF CAPSULAR POLYSACCHARIDES
• PCT/US2023/331540-2125, AEROTOLERANT BACTERIA FERMENTATION
- ISPPD Poster Presentation, 2024