Timothy Sharp

About Timothy Sharp

Experienced biobanking and laboratory operations professional focused on the biopharmaceutical industry with twenty years of combined managerial experience in project management, manufacturing, specimen management, and laboratory operations in the US and internationally. Tim has managed the largest human tissue and biospecimen repository in the United States for the National Institute of Health National Cancer Institute’s Central Repository. His work has been critical in supporting research for cancer treatment and prevention through the collection, distribution, handling, and storage of solid and liquid biopsies, blood products, multicohort collections, and finished pharmaceuticals and vaccines. Tim has directed operations for various large biorepositories including ICON Plc, ATCC, and Fisher Bioservices. Tim’s focus in recent years is quality systems in specimen management for cold chain logistics ranging from controlled room temperature finished drug products to liquid phase storage of tissues, embryos, and stem cells. He has developed and co-developed systems to ensure the temperature and tacking of specimens meant for drug discovery through transplant. His developments include automated systems, RFID technology, various temperature-controlled platforms, and software systems for metadata and specimen management.

Experience

1. Senior Scientific Subject Matter Expert - Clinical Development and Operations

   Tunnell Government Services, Inc.

   Jan 2025 — Present

   Supporting Biomedical Advance Research and Development Authority (BARDA)• Provide subject matter expertise for clinical trial, laboratory, and sample operations activities for preclinical through phase 4 trials.• Coordinates with various BARDA contract officer representatives, assisting in the development of contract solicitations, task orders, and operations, as well as sample and laboratory activities across BARDA, in partnership with contracted laboratories and pharmaceutical partners. • Advises the US Federal government on sample operations systems and laboratory operational standards across countries and regions.• Advises the US Federal government on laboratory operations for bioanalytical and central labs (diagnostic, bioanalytical, and clinical trials). • Provides design consultation for sample activities to improve analyte stability for primary, secondary, and advanced research activities in clinical trials.• Interconnects BARDA with industry leaders for cross-functional product or service development, focusing on specimen operations from collection through final distribution, including logistics, lab assessments, and repository operations.• Provides audit support for laboratory, sample management, and sample data activities for various clinical trials and operations.• Provides consultation for tissue for transplant banking and other materials for HCT/Ps.• Advises across agencies within the US Department of Health and Human Services (HHS), including the FDA, NIH, and CDC, on medical countermeasures developed under the Biomedical Advanced Research and Development Authority (BARDA). • Advises on select agent activities related to biosecurity and the development of medical countermeasures.• Serves on technical and business proposal panels for contract awards.

Education

• Fairmont State University

  Electro and Polymer Chemistry

  2000 — 2001

• Salem Teikyo University

  Molecular Biology

  1996 — 2000

• Hood College

  Biochemistry

  2008 — 2010

• University College Dublin

  Executive Business Leadership

  2017 — 2017

Skills

• Immunology
• Lifesciences
• Life Sciences
• Sop
• Fda
• Pcr
• U.s. Food and Drug Administration (Fda)
• Glp
• Hplc
• Standard Operating Procedure (Sop)
• Gel Electrophoresis
• Chromatography
• Dna
• Molecular Biology
• Microbiology
• Validation
• Elisa
• Cell Culture
• Laboratory
• Biochemistry
• Good Laboratory Practice (Glp)
• Genomics
• Biotechnology