Jesse McCool

Results-driven Operations Leader drives performance improvements and designs and leads strategic initiatives. Skilled manager of cross-departmental activities with adaptive communication of organizational objectives. Develops and executes innovative strategies for stimulating growth and service quality.

• Founder of Wheeler Bio
• Passionate Fundraiser for Various Charities including Emily Whitehead Foundation, Law Rocks, Juvenile Diabetes Research Foundation, Operation Birthday
• Engaged Community Leader
• Co-author of Build Back Better Regional Challenge Grant ($35 million award)
• Productive Government Affairs Work in D.C. and Oklahoma City

• AABP - Association for the Advancement of Blood and Biotherapies
• ISPE - International Society of Pharmaceutical Engineers
• Science Museum Oklahoma (Board of Trustees)
• Governor's Council on Workforce and Economic Development
• Governor's Business Roundtable
• National Security Council on Emerging Biotechnology

Founder, Start-up, and Capital Projects Experience:

·  Bionova Scientific (The Woodlands, TX): Site head responsible for $100 million capital project involving two facilities.  Project on-track and on-budget.

·  Wheeler Bio (Oklahoma City, OK): Co-Founder of niche CDMO startup focused on early-stage antibody projects and drug substance manufacture for first human trials. Led company from inception to first revenues.  Led four rounds of equity financing (Seed, Seed-2, A, and C-note round) raising $53 million.  Achieved meaningful company milestones while maintaining robust, scalable leadership culture.

·  Mascoma Corp (Lebanon, NH): R&D company that develops innovative fermentation ingredients such as TransFerm® and Convergence™. Mascoma was acquired by Lallemand in 2009.  I was a scientist on the start-up team and helped to develop the foundational genetic tools for organism development and fed-batch fermentation processes.

Government Affairs Experience:

·  BIOSECURE Act: Led Capitol Hill lobbying and messaging around BIOSECURE Act on behalf of Wheeler Bio.  Wrote two op-ed articles for the Oklahoman and met with state and federal congressional leaders on the matter in support of the state workforce development and the National Security Commission’s preliminary report on Emerging Biotechnology.

·  Appropriations: Supported two appropriations processes resulting in a $1.25 million budget award for a distributed manufacturing capability and a $10 million, multi-year Pathfinder budget line-item request for a Portable CMC® Lab installation at the Vanderbilt Vaccine Center in Nashville, TN.

·  Grant Writing: Architected and developed narratives, budgets, and scopes for two component projects of a $35 million EDA Build Back Better Regional Challenge proposal.  Grant was awarded in 2022 to our purpose-built coalition (Oklahoma Biotech Innovation Cluster) and both facilities are currently in operation featuring Wheeler’s platform process, Portable CMC®.

·  Business Roundtable: Served on the Governor’s Business Roundtable and Oklahoma Governor’s Council for Workforce and Economic Development.  Work with Representative Brian Hill at the State Capitol to facilitate statewide efforts to improve Oklahomans' exposure to high-demand career opportunities and to ensure education and training opportunities deliver the skills needed by the biomanufacturing industry.

Leadership Experience:

·  I am deeply committed to empowering and advocating for employees, fostering a culture of inclusivity, collaboration, innovation, and growth. I believe that people are a company’s greatest asset, and I prioritize creating an environment where every team member can thrive and reach his or her full potential.  Led executive leadership teams at two CDMOs to define north star targets and midterm operating plans.  For start-up company (Wheeler Bio), led the development of our corporate Vision, Mission, and Core Values in 2021 that helped to guide our operating model and employees.  Worked with Linden Leadership (Tom Goodell and Richard McDonald) for past six years to provide routine leadership development and coaching resources.

• Mobilized, motivated, and empowered engaged teams while fostering a culture of collaboration, high morale, and diversity/inclusion within a continuous improvement and learning environment to build a high-performing organization and engaged in increasing productivity.
• Used good communication and people skills and quickly built relationships and rapport with diverse groups of key stakeholders, executives, and peers. Expertly negotiated and influenced with impact, clarity, and enthusiasm. High retention of staff with high engagement scores.

·  Led the development of cultural pillars at Wheeler (team exercises). Our guiding principles set expectations for how employees behave when interacting with clients, colleagues, suppliers, and partners and provided clarity and direction for the choices made.

Customer Advocacy:

·  I am a passionate advocate for customers (internal and external), ensuring that exceptional services and customer-centricity are enforced. I prioritize listening to customers’ needs and delivering solutions that not only meet but exceed their expectations. A relentless focus on service excellence is key to success and growth.

·  Developed unique partnering approaches in CDMO (CRL, Alloy, ATUM, Vanderbilt Vaccine Center, NCTM, BioTC Oklahoma, Argonaut).

Technology Development Experience:

·  Portable CMC® - Led the conception of an open-source platform process for antibodies with proven scalability, robustness, reliability and portability.  Several installations are underway today for remote Portable CMC® Labs, a novel operating element in CDMO.  Oversaw the establishment of the technology development roadmap, annualized tech development goals, budgets, licensing, and marketing and press releases.

·  The Keystone Expression System® (PROTEIN PLATFORM) - Led enterprise R&D/innovation programming for establishing Cytovance’s proprietary microbial expression platform for recombinant proteins.  Was responsible for stakeholder alignment in Development, Commercial, Finance, Quality, and Manufacturing.  Led the technology development activities in Process Development through market launch and ultimately, several out-licensing deals during my tenure as CTO.

·  Cytovance’s pDNA Platform - Led multi-team R&D/innovation program for development of a pDNA platform using novel mixing technology (ImPULSE™) for improved scalability of chemical lysis.  Garnered capex support from multiple presentations given at headquarters in Shenzhen for business expansion into the pDNA market with additional spending in equipment, people resources, and cleanrooms.  Led Joint Venture (JV) conceptualization and presentation to large US CDMO at J.P. Morgan conference in 2018.   Launched Cytovance’s platform in 2019 with multiple media campaigns including Webinars and white papers.

·  Lonza’s pDNA Platform (2011) - Led 3-person R&D/innovation program for Lonza’s novel pDNA platform development and market launch.  Oversaw the ideation, planning, component licensing (HyperGRO® , chromatographic solutions, and Clean Genome® E. coli), process design and process development, analytical method development, and marketing content generation for the 2011 market launch.  A differentiated technology integrated into the platform was Clean Genome® E. colifrom Scarab Genomics to eliminate insertion elements and sequences of concern appearing in the final pDNA product.

Lallemand’s (Mascoma) TransFerm® fermentation ingredient for biofuels applications – genetically modified yeast strains.  Helped stand-up R&D facility (fermentation, strain development, analytics) and co-developed foundational tools and processes to support the development of genetically modified organisms which formed the basis of the TransFerm® technology.

Peer Reviewed

·  Agbogbo FK, Ramsey P, George R, Joy J, Srivastava S, Huang M, McCool J. Upstream development of Escherichia coli fermentation process with PhoA promoter using design of experiments (DoE). J Ind Microbiol Biotechnol. 2020 Oct;47(9-10):789-799. doi: 10.1007/s10295-020-02302-7. Epub 2020 Aug 25. PMID: 32844325; PMCID: PMC7658055.

·  Agbogbo FK, Ecker DM, Farrand A, Han K, Khoury A, Martin A, McCool J, Rasche U, Rau TD, Schmidt D, Sha M, Treuheit N. Current perspectives on biosimilars. J Ind Microbiol Biotechnol. 2019 Oct;46(9-10):1297-1311. doi: 10.1007/s10295-019-02216-z. Epub 2019 Jul 17. PMID: 31317293; PMCID: PMC6791907.

·  Tripathi SA, Olson DG, Argyros DA, Miller BB, Barrett TF, Murphy DM, McCool JD, Warner AK, Rajgarhia VB, Lynd LR, Hogsett DA, Caiazza NC. Development of pyrF-based genetic system for targeted gene deletion in Clostridium thermocellum and creation of a pta mutant. Appl Environ Microbiol. 2010 Oct;76(19):6591-9. doi: 10.1128/AEM.01484-10. Epub 2010 Aug 6. PMID: 20693441; PMCID: PMC2950449.

·  Barnard GC, McCool JD, Wood DW, Gerngross TU. Integrated recombinant protein expression and purification platform based on Ralstonia eutropha. Appl Environ Microbiol. 2005 Oct;71(10):5735-42. doi: 10.1128/AEM.71.10.5735-5742.2005. PMID: 16204482; PMCID: PMC1265954.

·  McCool JD, Long E, Petrosino JF, Sandler HA, Rosenberg SM, Sandler SJ. Measurement of SOS expression in individual Escherichia coli K-12 cells using fluorescence microscopy. Mol Microbiol. 2004 Sep;53(5):1343-57. doi: 10.1111/j.1365-2958.2004.04225.x. PMID: 15387814.

·  McCool JD, Ford CC, Sandler SJ. A dnaT mutant with phenotypes similar to those of a priA2::kan mutant in Escherichia coli K-12. Genetics. 2004 Jun;167(2):569-78. doi: 10.1534/genetics.103.025296. PMID: 15238512; PMCID: PMC1470904.

·  Sandler SJ, McCool JD, Do TT, Johansen RU. PriA mutations that affect PriA-PriC function during replication restart. Mol Microbiol. 2001 Aug;41(3):697-704. doi: 10.1046/j.1365-2958.2001.02547.x. PMID: 11532137.

·  McCool JD, Sandler SJ. Effects of mutations involving cell division, recombination, and chromosome dimer resolution on a priA2::kan mutant. Proc Natl Acad Sci U S A. 2001 Jul 17;98(15):8203-10. doi: 10.1073/pnas.121007698. PMID: 11459954; PMCID: PMC37422.

Conference Presentations

·  Ornek D, Hamilton M, Chopra M, Kennedy B, Anderson R, McCool J, Ramsey P.  Characterization of a Biomanufacturing Fermentation Process Using New DOE Approach: Definite Screening Designs.  BioProcess International Journal Website, November, 2012

·  Ornek D, Hamilton M, Chopra M, Kennedy B, Anderson R, Lin W, McCool J.  Effects of Temperature and Feeding Strategy on pDNA Production in E. coli Fed Batch Fermentation.  Annual Boston Bacterial Meeting (BBM2012), June 7-8, 2012, Harvard University Science Center, Boston MA

·  Conference co-chair. Session titled “Integrating Fermentation Process Design and Downstream Processing”, RAFT IX (November 2011).

·  Conference speaker. Talk entitled “XS Microbial Expression Technologies with Case Study”, SIM Annual Meeting (August 2010).

·  Webinar author (S. Palmieri, J. McCool, and F. Blattner). Entitled “pDNA Production and Purification”,  Bioprocess International (July 2010).

·  Tripathi S, Olson D, Argyros A, Miller B, Barrett T, Murphy D, McCool J, Warner A, Rajgarhia V, Lynd L, Hogsett D, Caiazza N.  Development of pyrF-Based Genetic System for Targeted Gene Deletion in Clostridium thermocellum and Creation of a pta Mutant.  Appl Environ Microbiol. 2010 Oct;76(19):6591-6599.

·  Conference speaker. Talk titled “Development of improved plasmid DNA production using Clean Genome E. coli”, RAFT VIII (November 2009).

Op-Ed and Marketing

·  McCool J. Why domestic U.S. production for lifesaving drugs is mandatory or innovation will die (The Oklahoman 2024)

·  McCool J. How Oklahoma can help reduce America’s dependence on offshore biotech services (The Oklahoman 2024)

·  McCool J, Schmidt D, Beske O, Monks S. The Biopharma Industry is Well Prepared for an Overhaul of the Lead-to-Clinic CMC Process for Antibodies (July 2023) Pharma’s Almanac

·  McCool J. Rethinking the Conventional CDMO Model (July 2024) Pharma’s Almanac.

·  McCool J. Overcoming Development Challenges with Digital Solutions (May 2024)

·  McCool J. How Synergistic Collaborations Between Outsourcing Partners Can Accelerate Clinical Success (April 2024)

·  McCool J. Leveraging Innovative Transposase Technology for a Highly Reliable and Productive CMC Platform (March 2024)

·  McCool J. Revolutionizing Early-Stage Biopharma Development: Introducing Wheeler Bio’s Portable CMC® Platform (January 2024)

·  McCool J. Reducing Time to IND, Increasing Quality, and Building Trust Through Shared Data (August 2022)

·  McCool J. Integrating Cell Line and CMC Development (2022)

·  McCool J. Applying an Advanced Pharma 4.0 Perspective to Design the Facility of the Future (2022)

·  McCool J. Analyzing Bioreactor Sizes from Lab to Clinical Production

·  McCool J. Why Reshoring Small Batch Pharma Production is Critical for Biotechs

·  McCool J. 5 Challenges to the Biotech Journey and How to Overcome Them

·  McCool J. 5 Techniques for Recombinant Protein Expression

·  McCool J. Optimizing Upstream Process Development in Biotechnology

·  McCool J. From Vector Design to Process Characterization: A Biotech Journey

·  McCool J. 8 Innovative Technologies Streamlining Early-Stage Antibody Development

·  McCool J. Benefits of operating within an innovation hub ecosystem

·  McCool J. Top 5 Ways that Portable CMC™ can Benefit your Antibody Development Program

·  McCool J. An agile approach streamlines the path to clinic for novel monoclonal antibodies

·  McCool J. Shortening mAb development timelines with accelerative CMC strategies