Melissa Siddons Johnson Email & Phone Number

United States

Administrator for Veeva LIMS

Richmond Va

Richmond, Virginia Area

Richmond, Virginia Area

Laboratory manager then Director for Richmond VA site

Richmond, Virginia Area

Formerly Arista LaboratoriesHPLC, GC, and LCMS analysis of components of tobacco smoke (carbonyls, phenols, TSNAs, HCN, nicotine, etc). Extract and isolate analytes of interest from trapping solution and/or filter pads exposed to smoke via liquid and SPE separation techniques. Analyze these compounds via HPLC, UPLC, GC, LCMS, and CFA. Bench work includes preparation of all standards and solutions used in analysis; set up and maintain instruments as well as troubleshooting. Accomplishments Site trainer for analytical methods and SOPs. SOP writer and reviewer as well as technical review for analytical methods. Frequent/daily use of MassLynx and Empower data software acquisition systems. Serve as Empower administrator and trainer. Experience with Excel and electronic notebook software.

Richmond, Va

Formerly Pfizer Consumer Healthcare, RichmondFormerly Wyeth Consumer HealthcareAnalyze samples for release and stability studies using HPLC, GC, FTIR, and dissolution. Prepare samples via dilution or extraction prior to analysis. Instrumentation set up and troubleshooting during analysis. Learn and apply GMP and department SOPs. Document daily work in laboratory software along with all data generated. Programs used include LabWare LIMS, Empower CDAS and SAP as well as Microsoft Office. Lead Investigator for the Analgesic/Respiratory Primary Processing Unit Laboratory (ARPPU Lab), Dedicated Lab Trainer for on boarding of new employees and continuing education of lab personnel. Conduct laboratory investigations on Out of Specification (OOS) and atypical results; write investigative protocols, evaluate data and write up findings. Train incoming analysts on SOPs, instrumentation and software. Conduct peer review on data for other analysts. Obtained Red Belt in Six Sigma.

Responsible for the day-to-day activities of direct reports. Conduct numerous studies simultaneously, meet deadlines, ensure quality, review all chromatography and data generated by junior staff, communicate with clients, and ensure overall productivity for all studies. Serve as a resource for my team in troubleshooting instrumentation, extraction procedures and overall understanding of day-to-day activities. Responsible for presenting junior staff with new assignments, training junior staff and evaluating progress with new techniques. Participate in weekly scheduling meetings to evaluate current workload and bimonthly meetings with management to evaluate department progress and needs. Responsible for data generation and submittal to QA and subsequently, the client.

Reviewed project data, notebooks and designed the department quality control process. Assisted in final bioanalytical report preparation. Responsible for communication with department managers or group leaders concerning assigned projects and provide updates on progression or problems. Reviewed and approved notebook entries made by junior staff.

The following duties are in addition to the Associate Scientist duties: plan and organize work with minimal supervision; provide assistance and training to Associate Scientists; set up and maintain analytical data in regards to acceptability and consistency; problem solve, either independently or with assistance, extraction and/or instrumentation problems. Analyze samples via HPLC and LC/MS.

Designed tables and figures for presentation of data prior to writing analytical report, interpreted computerized data output to develop text for analytical reports, and compiled raw data and statistical summaries from laboratory database into a client specified format. Ensured that hard copy and electronic reports are consistent and complied with required formats.

Responsibilities in this role were as follows: extract biological matrix samples to determine the levels of analytes of interest; read, comprehend and carry out laboratory activities according to Standard Operating Procedures; perform daily work assignments accurately, timely and in a safe manner; conduct extraction procedures following written method or instructions; learn routine operation, maintenance and theory of analytical instrumentation; communicate project status to project leader; maintain laboratory/project notebook as required by the Standard Operating Procedures.

(Temporary Employee)Responsible for analyzing samples for process validation, cleaning validation, stability studies using High Performance Liquid Chromatography, Gas Chromatography, Conductivity, Atomic Absorption, Spectrophotometry and Moisture Determination. Prepared samples via dilution or extraction prior to analysis. Responsible for learning GMP and the department SOPs. All daily work was documented in laboratory notebooks along with all data generated. Programs used included Microsoft Excel and Word.

Bs, Chemistry

Activities and Societies: Alpha Phi Omega National Service FraternityCharter President, Alpha Delta Iota Chapter, Alpha Phi Omega

Chemistry

Activities and Societies: Alpha Phi Omega National Service Fraternity