Jeff Schumack has over 30 years of experience in the IT industry, mostly in the biotechnology sector. His experience includes managing complex projects, leading multi-disciplinary teams, building validation programs in response to regulations including FDAs 21 CFR, Part 11, architecture and development of custom laboratory software, and a deep understanding of business processes used by Clinical Research & Development organizations.
Jeff has been instrumental in building the BioIT Solutions’ molecular diagnostics and clinical platforms to support the growing needs of diagnostics and bio/pharmaceutical companies. He has worked closely with clients to implement enterprise systems that address the unique requirements of these industries.
Jeff was the Associate Director of Clinical & Regulatory Systems at Human Genome Sciences. In this role, he directed the implementation of a clinical and regulatory informatics infrastructure to support HGS’ clinical trials. Jeff successfully implemented this program by working closely with all groups in the research and development organization including; clinical data management (Clintrial, Integic), clinical operations (CTMS), clinical immunology (CSTrack), drug safety (ARISg), regulatory affairs (Documentum and Insight Publisher) and biostatistics (SCE).
Jeff was instrumental in the creation of HGS’s computerized system validation program, serving as the lead IT interface for all validation activities. He authored several Policies and SOPs in support of this program. Jeff was also the lead IT contact on IT matters during FDA and partner audits.
While a majority partner at TSI Consulting, Inc., Jeff managed several client accounts providing IT services to biotechnology companies. He and his team developed custom applications for various clients including companies performing biologic testing and Genomic research.
Jeff has presented his work at a number of conferences including; the American Statistical Association, Immunogenicity for Protein-Based Therapeutics and EMCs Momentum conference.
Jeff earned a BS degree in Computational Mathematics from Michigan State University, East Lansing, Michigan.
Learning from Experience
By Mike Fannon. During my long tenure with Human Genome Sciences (from late 1992 through 2005), I had the good fortune to participate in a biotech startup from the ground floor. It was a real learning experience to work for an entrepreneurial company staking a claim on the genomic frontier in the mid 1990s.