1. Day to day supervision of test performance by testing personnel.2. Monitoring laboratory processes to ensure acceptable levels of analytic performance are maintained, to include review of quality control, instrument and equipment maintenance, and other quality assurance activities.3. Organize/assign work to appropriate staff.4. Validate new instruments and new assays.5. Create, revise or discontinue laboratory SOPs.6. Interact with government and other agencies (e.g. State Health Department, CAP, DEA, OSHA, NJDOH, NYDOH, etc.) as appropriate.7. Organize educational/training/safety activities for technical and non-technical personnel.8. Monitor performance, check instrument maintenance logs and maintenance activates.9. Perform and provide instructions to technical personnel when necessary.10. Participate in monthly meetings with Medical Director.11. Review and retain monthly quality improvement indicators' data.12. Update quality indicators and/or benchmarks as needed.13. Monitor PT performance and corrective actions taken as appropriate.14. Interact with the reference laboratories to ensure quality of the results.15. Set up/updates LIS.16. Participate in selection of appropriate technical personnel.17. Review of LC/MS-MS analysis data to insure clinical acceptability.18. Review of Chemical Analyzer data to insure clinical acceptability.19. Accurately entering and reporting test results.20. Remaining current on lab standard operating procedures.21. Training and competency evaluation for all staff. Training should include objectives for training in order to develop all necessary competencies required to perform job duties.

Review and certify negative and positive results for Federal and Non-Federal drug tests based on quality control acceptance criteria, immunoassay data, and interpretation of gas and liquid chromatography.Document results on external Chain of Custody form as neededKnowledge of EMIT, DRI and CEDIA including SVT theories Profound knowledge of SAMHSA guidelines and principles of operation of screening instrumentation (Olympus), GCMS, LCMSMS, GCHS, pH meter, and refractometer for specific gravity

1. Lead bioanalytical projects that were outsourced to CRO’s and in-house projects that involved supervision of an analytical chemist and a junior scientist.2. Developed, validated, and improved bioanalytical assays utilizing LCMS/MS and UPLC-MS/MS fast analysis of drug candidates including peptides, proteins and small molecules from preclinical, clinical and GLP sample matrices. 3. Managed the analysis of clinical and pre-clinical samples at CRO's using validated bioanalytical assays developed in-house for the DMPK group.4. Successfully defended GLP studies that I managed as lead scientist before the FDA during impromptu study audits.5. Preparation and periodic review of departmental SOP’s, analytical reports and NDA and IND submissions.6. Ensured that the GLP status of the DMPK group facility was maintained including the LC-MS/MS labs and automation labs. Regular calibration and maintenance of instruments was supported. Thorough records were kept for all calibration and maintenance activities involving analytical equipment. 7 Prepared quality GLP analytical reports and documents for submission to regulatory agencies. Served on local project teams as a bioanalytical manager.

• Development of bioanalytical LC-MS/MS GLP assays for multiple drug candidates dosed simultaneously via an N-in one cassette dosage.• Responsible for the conduct of many preclinical GLP studies under the scrutiny of internal auditors for the DMPK group as lead scientist.• Bioanalytical method development and GLP method validation of several online extraction assays utilizing a Cohesive system.• Direct Plasma injection assay developed for several discovery projects.• Blood versus Plasma assays and incubations of new drug candidates.• Participated in an offsite Bioanalytical Immunological Methods Laboratory Course as an introduction to ELISA analysis of proteins in biological matrices.• Designed an bioanalytical method to measure Adenosine (Biomarker for Asthma) in Monkey BAL Fluid.• Took part in several LC-MS/MS courses taught by Dr. Jack Henion from Cornell University.• This position is associated with: