Brian Nofsinger Email & Phone Number

Durham, Nc, Us

Durham, North Carolina, Us

• Direct OpAns’ regulated and non-regulated LC-MS/MS and immunonalytical (MSD, flow cytometry, plate reader, qPCR, and chemistry analyzer) bioanalytical groups in support of discovery, GLP, and clinical including biomarker companion diagnostic testing.• Develop new customer relationships and manage existing customer relationships.• Schedule all personnel and instrumentation resources to meet client and revenue needs.• Defended an FDA CDER audit without issuance of a 483.

Durham, Nc, Us

• Directed regulated and non-regulated in vitro permeation testing (IVPT), in vitro release testing (IVRT), a quantitative LC-MS/MS group, and a skin biology group supporting formulation development and manufacturing for topical and dermatological pharmaceutical research and development.• Defended and resolved audits including an FDA GLP pre-approval inspection without issuance of a form 483.• Provided hands on method development and direction including acting as the primary point of contact for the most scientifically challenging of client projects.

Princeton, New Jersey, Us

• Oversaw and coordinated personnel and resources to meet scientific, regulatory, and financial objectives for a division generating $7 million of annual revenue.• Responsible for P&L.• Hosted hundreds of successful client and regulatory agency (FDA, NCDHHS, DEA, and NCDENR) audits, resulting in the acquisition of a CLIA Certificate of Compliance.• Provided scientific guidance for bioanalytical LC-MS/MS method development and validation including scientifically challenging assays (e.g. endogenous biomarkers including protein quantification requiring fit-for-purpose biomarker validations).• Established and led a bioanalytical LC-MS/MS division from genesis at Enthalpy Analytical through acquisition by LabCorp filling all roles as necessary (e.g., quoting, contracting, method development, bench chemistry, reporting, quality control, etc.).• Created the transition plan following the acquisition of Enthalpy Analytical’s bioanalytical division by Tandem Labs, a LabCorp company.

• Identified and solicited prospective clients.• Developed new bioanalytical assays.• Managed all Project Managers.

Ph.D., Chemistry

B.S., Chemistry