Steven Bates Email and Phone Number

• Scientific informatics consulting for clients in the biopharma space.• Writing knowledge articles about scientific data management• Exploring AI tools to support laboratory research

• Collaborated with on-site manager to draft computer systems validation SOP, as well as to complete final phase of LIMS vendor selection, initiating CMC group’s digital transformation and establishment of FAIR data standards.• Interviewed members of group (~10) to elicit user requirements, map workflows for receiving lot release and stability reports from CDMO partners, and gain their trust to begin to acclimate them to the benefits of a LIMS.• Organized information inferred from paper reports of GMP test data (~200 tests with ~400 fields for 15 biologic drug products and intermediates, across 12 CDMOs) into a single framework to establish naming conventions and prepare for LIMS master data import.

• Documented LIMS requirements and NGS laboratory workflows, and led vendor selection for a system compliant with both CLIA and 21 CFR Part 11, to commercialize liquid biopsy test for early detection of pancreatic cancer.• Responsible for communications with external development team through their project manager and business analyst, to address bugs and other issues, request features, build SQL queries to retrieve QC metrics from LabVantage databases, draft and approve functional requirement specification documents, and any other areas of discussion necessary to the project.• Generated user guides, validation plan and reports for LabVantage and, in collaboration with bioinformaticians, validation plan for ClearNote's custom machine learning models.• Managed, organized, and prioritized backlog of JIRA tickets, periodically assigning them to development team, validating results in test environment, and documenting change requests for deployment to production.

• Assisted in collecting master data and SOPs in support of LabVantage implementation • Gathered and documented LIMS requirements and laboratory workflows and led vendor selection in preparation for implementation of CLIA compliant system

• Generated design documentation, requirements, test plan, validation report, and user instructions for clinical CRO, to bring one of their processes in line with regulatory requirements, as well as suggesting and implementing improvements to streamline the process and make validation more user-friendly.• Developed and implemented NGS, microarray, qPCR, and proteomics CoreLIMS applications and solutions, including generating requirements, UATs, and installation instructions, in support of the vendor's marketing and sales efforts.

NOTE: THESE ROLES CONTINUE PROGRESSION OF LABANSWER EXPERIENCE FOLLOWING ACQUISITION• Developed and implemented CoreLIMS end-to-end solution for single cell genomics product• Helped onboard and train new hires and otherwise contributed to the high reputation of client-facing project team throughout LabAnswer acquisition process, leading to contract renewal and expansion

• Continued CoreLIMS project through Labanswer acquisition process• Applied business process mapping notation to document general PCR workflow for teaching lab assistants

• Supported launching of in-house teaching laboratory by aiding in the creation of lesson plan for demonstrating the polymerase chain reaction, and led a team designing a poster to summarize the history of PCR and its impact in biotechnology research and industry • Researched, wrote and delivered internal presentation on the background and future potential of CRISPR• Developed and implemented CoreLIMS applications for pathology and for preclinical in vivo studies

• Developed and implemented CoreLIMS applications for protein analysis, including generating requirements, UATs, and installation instructions• Completed internal training modules for SQL, LIMS, Testing and Validation, Business Analysis, Agile. and Pipeline Pilot, as well as external CoreLIMS modules, enabling rapid onboarding to project with software vendor

Provided technical expertise and contract work as needed to biotech startup accelerator program.

As one of initial recruits to business team, developed models for target markets for blood diagnostic product. I created and developed relationships with US Army contacts interested in clinical research and funding partnerships, as well as relationships with prototyping, manufacturing and supply partners.I wrote, and submitted reports concerning healthcare markets, funding opportunities, and regulatory requirements, as well as contributing technical writing and planning to grant applications and assisting in the planning of service design brainstorming sessions.Finally, I led the search for in vitro medical device regulatory consultants, conducted initial screening interviews, and presented the most promising candidates to the CEO.

Cultured Lactobacillus for DNA transformation and offered input on DARPA grant proposal.

Setting up and testing an emulsion PCR systemSupport writing SBIR grant response

I spearheaded a project to develop molecular biology-based tools and strategies to improve the genetic analysis of cell types, with a long-term goal of achieving single-cell resolution when applied to bulk tissue samples.

My PhD thesis project focused on using microfluidics to discover protein-protein interactions in E. coli, as well as developing general microfluidic methods for measuring the affinity and kinetics of protein-protein, protein-DNA, and/or protein-RNA interactions.

I learned standard molecular biology lab techniques, expressed and purified protein to support a graduate student's structural biology project, and led my own projects developing novel approaches for antisense therapeutics and DNA microarray design.