Thomas J. Schneider Email & Phone Number

Lead and guide strategic planning, program effectiveness, and project outcomes to offer quality consultative services to biopharma organizations. Ensure regulatory compliance across every stage of drug development involving therapeutic advancements.• Direct and mentor 14 Managers, Scientists, and Analysts, guide Team Flow, and reinforce Team and Technical Agility to achieve results.• Join company scientists and organizational resources with client scientists to proactively anticipate assay challenges, monitor project progress, and achieve objectives.• Validate compliance with internal and external requirements, client protocols, policies, and regulatory requirements through a focus on quality, scientific oversight, and cost controls.• Appointed as the BioMarker lead to support large molecule, small molecule, and Advanced Therapy Medicinal Products (ATMPs) during the drug development process.

Led eight Scientific Team members in the development and validation of assays, especially Flow Cytometry and cell-based assays. Ensured compliance on preclinical and clinical trials to accomplish all requirements and protocols for regulatory, good laboratory practice (GLP), good clinical laboratory practice (GCLP), College of American Pathologists (CAP), and clinical laboratory approvement amendments (CLIA).• Recognized by colleagues and clients as a subject matter expert in Flow Cytometry, Statistics, and Bio-assay design.• Streamlined communication and collaboration across a highly matrixed, cross-functional team to meet client goals.

Cambridge, Ma

Directed 2+ team members in the design, planning, implementation, testing, qualification, and validation of numerous cell-based and ELISA-based assays to support biologics characterization.• Implemented a novel method to clone hybridoma immunoglobulin variable region heavy and light chain genes for expression.• Coordinated comprehensive in-process impurity and stability testing to identify contaminants from residual solvents and process-related impurities.

Established the Tumor Immunology discovery-stage research program with colleagues based on a presentation at a company Innovation forum. Gained program approval from Merrimack executive leadership.• Used novel lipid nanoparticles to guide tumor cells to provoke anti-tumor immunity.• Designed a high-throughput FACs-based screening assay of ex vivo murine splenocytes to identify candidate immune activators resulting in a lead molecule.• Supervised team members to investigate the development of novel cell adhesion inhibitors for the treatment of autoimmune and inflammatory diseases.• Coordinated and motivated Cell Biologists, Protein Chemists, and Modelers to understand the biophysical characteristics and potency of test molecules.

Directed and coached three team members to investigate the mechanism of action (MOA) of MM-093 recombinant human alpha fetal protein (AFP). Designed and coordinated in vivo analysis of MM-093 in animal models of auto-immune and inflammatory disease (EAE and collagen-induced arthritis).• Introduced various orthogonal techniques, multi-parameter flow cytometry, BrDU apoptosis assays, and proliferation assays to evaluate MM-093.• Connected internal team members and resources to implement MatLab software and high-content data sets.• Promoted to Principal Scientist based on leadership skills and a successful track record guiding multicultural team members to challenge the status quo through empowerment, creativity, accountability, and open communication.

Awarded NIH funding to complete two projects: 1) Generated knock-in mice expressing a mutant complement receptor. 2) Demonstrated receptor editing in developing B cells Elucidated tolerigenic mechanisms operative during the development of transgenic (HEL; Hen Egg Lysozyme) B cell progenitors.

Cloned a novel gene, faim, which confers resistance to Fas-mediated apoptosis. Taught myself differential display (a technique to clone genes) for this project.Published faim paper in the Journal of Experimental Medicine.Spoke at Keystone Symposium to describe this work.Awarded patent as a result of this work.KEY SKILLS Motivated learner of new software, techniques, approaches.Management and oversight of full time employees.Recognized Expert and resource for FACs/cell sorting (certified FACs Aria operator, adept with Coulter iEpics/Elite instruments).Design, execution and oversight of in vivo animal models of auto-immune and inflammatory disease- EAE, NOD, and Arthritis. Translational research: immunologic cell-based assays of ex vivo clinical samples. Clinical trial design, oversight, and guidance of CROs.All aspects of gene cloning, protein expression and purification. Data analysis employing multiple formats including MatLab, GraphPad Prizm and Excel.

Phd, Immunology

Activities and Societies: worked my face off cloned a novel gene, faim Dissertation: "Genes involved in the generation of Fas-resistance.

B.S