Sandra Wright Email & Phone Number

Basel, Ch

• Performs routine and some specialized Quality Control (QC) clinical grade product testing in support of the development, production, release, and distribution of Hepatocytes, Clonetics™, and Poietics™ products according to cGMPs for research use in cell therapy, gene therapy, and drug therapy.• Perform cell-mediated bioassays such as flow cytometry, immunofluorescent and cytochemical staining, morphology and growth/proliferation studies, cell count/viability and primary cell based assays• Cell performance testing and differentiation of mesenchymal stem cells into various lineages (i.e. osteogenic, adipogenic, chrondrogenic) • Performs lab investigations with supervisor oversight• Performs general lab support activities such as housekeeping, equipment QC and maintenance, inventory/ordering of supplies as needed• Writes/revises/assists with Standard Operation Procedures in support of cell therapy products• Provides support to QC projects• Trains on basic procedures and oversees work of entry-level analysts• Participates in technology transfer of customer documentation and testing protocols• Assists with execution of equipment validations (IQ, OQ, PQ)• Prepares samples and maintains appropriate records for submission of samples to contract testing labs• Records, analyzes, and maintains data• Serve as Subject Matter Expert (SME)• Lean Six Sigma, 5S, CAPA competent to support GMP environment and/or activities

• Performing, interpreting, and monitoring liquid culture drug susceptibility testing and conventional susceptibility testing under BSL-3 conditions for drug resistant strains of Mycobacterium tuberculosis to determine the most effective patient therapy • Raw processing of incoming clinical specimens (sputum, urine, blood, fecal, tissue) from county health departments • Troubleshoot equipment malfunctions and perform quality control, calibration, and maintenance as needed • Lead/support execution of in site projects and development, defining, and implementation of analytical methods (i.e. switch from VERSA to MGIT for susceptibilities) • Microbial identification and species differentiation via molecular and chromatographic analysis (qPCR, HPLC); Peer review of HPLC chromatography • Perform basic wet chemistry techniques (pH, conductivity, TOC, UV spectrophotometer) involving water samples in Inorganic Chemistry Lab • Write, revise and review SOPs, analytical methods, and other technical documents per QA standards • Quality assessment for deviations, laboratory OOS investigations and change controls related to test methods, SOPs, and analytical instrumentation; Document QCI data and investigations • Perform biochemical assays to characterize and/or differentiate mycobacteria spp. • Authors, reviews, and approves technical documents (test methods, validations, studies, operating procedures) • Train analysts in operation of equipment, test methodology, computer applications and safety procedures; Review and revise training materials; Identify training needs within staff • Act as a liaison with support departments on technical inquiries and test results; Active participant in cross-functional team • Effective organizational skills; Ability to multi-task, adapt to changes in operation, and coordinate multiple activities in parallel • Adherence to quality standards governed by current GLPs, SOPs, and company policies

• Raw processing of incoming clinical specimens (tissue, urine, fecal, blood, environmental) as well as immunological and serological rapid testing using approved SOPs and instrumentation to aid in patient diagnosis and treatment • Review of raw material specifications for testing requirements (cancel test orders if criteria are not met, request sample recollection/resubmission); Review analytical data associated with testing to ensure compliance • Support development, validation, and transfer of analytical methods (i.e. virus-specific cartridge to molecular panel Biofilm Array) • Perform quantitative and qualitative PCR-based testing in accordance with standard operating procedures (detection of various infections and viruses, biofilm microarray for pediatric respiratory infections and gastrointestinal infections) • Operational knowledge of analytical chemistry/microbiology laboratory equipment; Recognize problems and initiating troubleshooting steps to evaluate testing failures and other problems • Supports regulatory audits and investigations • Review SOPs and other work instructions for analytical instrument operation and test methods, ensuring alignment with qualification documentation • Train analysts in operation of equipment, test methodology, computer applications and safety procedures • Effective organizational skills; Coordinate the work of other testing staff in the department; prioritizing, assigning and reviewing work • Adherence to quality standards governed by current GLPs, SOPs, and company policies • Working knowledge of LIMS and data entry

Act as a liaison between courts and defendants, providing the funds required to release from custody a defendant who is awaiting trial. If defendant fails to appear in court on the specified date , bail agent must track down the defendant or hire a bail enforcement officer to do so (within a period of time set by the courts). If defendant can't be located within that time period, bail agents must forfeit the entire bail amount

• Conduct routine processing in lieu of quality control using compendia microbiology methods for survey and inspection food samples in an ISO-accredited laboratory to ensure safety for human consumption in adherence to FDA laws and regulations • Perform qualitative analysis (PCR and ELISA) in accordance with standard operating procedures for detection of potentially harmful microorganisms • Accurate documentation of data/lab results and review of official lab documents such as SOPs and technical reports • Support execution of transfer, qualification, development, and validation of analytical methods (i.e. implementation of Pathatrix for detection of EHEC) • Author, co-author, revise SOPs and technical reports in accordance to approved laboratory methods; Peer review and verification prior to reporting or submittal • Perform biochemical assays to characterize and/or differentiate microbial organisms • Troubleshoot equipment malfunctions and perform quality control, calibration, and maintenance as needed • Participates on project teams and collaborates throughout the project lifecycle ensuring analytical data compliance (i.e. outbreak investigations) • Train analysts in operation of equipment, test methodology, computer applications and safety procedures • Adherence to quality standards governed by current GMPs and company policies during outbreak investigations • Effective organizational skills; Ability to multi-task, coordinate multiple activities in parallel, and adapt to operational changes

• Provided technical assistance in ongoing laboratory projects at a graduate level; Research findings matured into individual project that formed the baseline for my Master’s thesis • Lead design and execution of lab experiments to support graduate project (potential transfer of Campylobacter between animal hosts and their antibiotic resistance patterns while produced in close proximity) • Raw processing of incoming fecal and tissue samples from animal hosts; Review of associated data with raw testing • Preparation and presentation of research findings (data) • Execute transfer, development, improvement, and validation of bioassays (i.e. PFGE electrophoresis for strain typing) • Molecular applications (qPCR, PFGE, fla-typing) to identify and/or differentiate Campylobacter spp. • Operational knowledge of analytical microbiology laboratory equipment; Supports maintenance and troubleshooting to ensure diagnosis of problems and identifying appropriate actions of laboratory systems • Adherence to quality standards governed by current GMPs and company policies of commercial facilities during investigations • Use of Bionumerics software to analyze genetic fingerprinting data and establish trends • Effective organizational skills; Ability to multi-task, adapt to changes/challenges, and coordinate multiple activities in parallel • Participates in multidisciplinary project team meetings (Poultry Science and Animal Science departments) • Maintain collaborative relationships with advisors, farm owners, and Vet School; Mentored as part of St. Augustine’s Summer Internship Program • Authored (or co-authored) manuscripts for publication; Presentation of research findings to inform and educate Progression to Research Specialist: NCSU Food Science Graduate Program- Master of Science Aug 2004-Dec 2006 ; Research Technician III May 2003-Aug 2004 (Acceptance into Master’s Program); Undergraduate Research Technician Sept 2002-May 2003 (Promotion)

Master Of Science (M.S.), Food Science

Bachelor Of Science (B.S.), Food Science

Bachelor Of Science (B.S.), Animal Sciences