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Data Entry Management

Location:
Gilbertsville, PA
Posted:
March 16, 2018

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Resume:

Joan M Girard

ac4t2k@r.postjobfree.com (h):610-***-****

https://www.linkedin.com/in/joan-girard (c):610-***-****

Research and Development Scientist

Research and Development Scientist with expertise in the pharmaceutical industry specializing in assay development and Bioassay, Biochemical, and Soil Characterization assays. Team player who collaborates across functional areas to provide quality delivery of results. Experienced in GMP laboratory, laboratory management and manufacturing settings, SDLC, Trackwise, Deviation Management, and Project Management. Very adaptable to change. Adept at prioritizing and successfully meeting multiple deadlines while paying close attention to detail.

PROFESSIONAL EXPERIENCE

MERCK, SHARPE AND DOHME, West Point, PA 1988-2018

Scientist June 2014- January 2018

Bio-Process GXP Systems

Performed assay development and Bioassay, Biochemical, and Soil Characterization assays including Simple Wes protein analysis, ELISA, cell based potency assays, HPLC, titration methods, UV/Vis, Quantitation, Gravimetric and TOC Cleanability, Recovery, TOC, and pH/conductivity on a variety of sample types including APIs, drug substance, drug product, process intermediates and innumerable chemicals in a GMP environment.

Knowledgeable in full application of sound scientific principles, theories, concepts, and techniques

Proficient in collecting and interpreting information with scientific rigor, as well as, conceiving, developing, and implementing solutions to projects while utilizing critical thinking to determine path forward in time critical and challenging situations

Effectively provided direct support for clinical campaigns, projects, capital, and initial and continuing cleaning validation studies; areas supported include on-site and above sites locations, both in the US and internationally.

Maintained GMP laboratory environments to ensure state of readiness for internal and external inspections and audits

Authored Standard Operating Procedures (SOPs), Assay Procedures (APs), Qualification Procedures, Qualification Reports, Position Papers, Memos and Result Analysis

Strongly advocated collaboration of resources within department as well with other on-site and off-site areas to foster an atmosphere of efficiency and inclusion

Actively planned and executed personnel training

Successfully executed troubleshooting and maintenance of equipment around testing schedules

Performed change control of instrumentation through SDLC

Performed process optimization and method developments which included stability, accuracy, precision, linearity, and robustness testing

Trained new employee to take on role of laboratory lead in Cleaning Validation Laboratory

Developed training plan and timeline to effectively train new scientist in lab lead role and transition them into role. Determined required electronic training.

Successfully trained new scientist while also performing laboratory analysis

Authored and provided document listing required functions of the lab lead and timing for execution of these requirements

Performed data review of new employees data to ensure lab analysis was performed according to GMP requirements

Transfer of residual BSA ELISA assay from manufacturing division to research division for use as release test for drug substance samples to support clinical supply

Collaborated with laboratory group where assay was used as a release test for manufactured vaccines to obtain procedure to tailor for use in research in GMP bioassay lab

Authored procedure for required use, garnered document approval and trained other laboratory personnel to perform method

Obtained required reagents and supplies required for analysis

Performed assay qualification of method

Qualified antibodies required for execution of analysis

Successfully performed release testing as per release protocol, producing results which met all acceptance criteria

Project Manager

Proficiently led numerous special projects, in addition to routine analysis

Provided leadership to team members to facilitate execution of testing in an organized manner

Effectively led team and collaborated with above site groups, quality groups, vendors, lab support groups and management to meet aggressive timelines while maintaining GMP compliance

Provided communication with Senior Leadership supporting projects to obtain approvals

Laboratory Specialist May 2012 – June 2014

Cleaning Validation Laboratory

Transitioned to Lab Lead role

Provided management of laboratory activities by training and mentoring lab personnel, prioritized scheduled lab analysis, author SOP’s, troubleshoot analyzer and testing issues, approval of documentation and maintained close relationship with Quality to ensure lab was always in a GMP inspection ready state

Provided TOC, conductivity and soil characterization analysis for process intermediates, culture media, reagents and commercial products for on-site projects, as well as, above site projects

Collaborated with lab personnel to develop method process improvement

Ensured all laboratory analysis performed with a “Safety First” mindset

Supported implementation of electronic chemical inventory system

Served on Safety Committee

Participated and led training initiatives of Inclusion

Staff Scientist April 2008-May 2012 Cleaning Validation Laboratory

Performed routine TOC and conductivity analysis to support cleaning validation processes to support clinical supply production

Performed soil characterization analysis for process intermediates, culture media, reagents and commercial products for on-site projects, as well as, above site projects

Performed maintenance and calibration of TOC analyzers

Assisted with SOP update

Ensured lab met all inspection readiness criteria

Laboratory Technician – Biochemistry July 1994-April 2008

Quality Operations

Testing responsibilities included quantitative and qualitative biochemical testing of final product,

Process intermediates, raw materials, stability and research samples as per CP’s and SOP’s in a GMP environment

Testing methods included: LAL, TOC, gel electrophoresis, ELISA, rate nephelometry, ouchterlony,

RIA, EIA, HPLC, protein chemistry and spectrophotometry

Data entry utilizing LIMS

Prepared reagents required for analysis

Maintained documentation as per company and regulatory policies

Laboratory Technician – Virology September 1990-July 1994

Quality Operations

Responsibilities included growth and maintenance of cell lines, infectivity titration assays for several

vaccines, plaque formation, agglutination, fluorescence, and cytopathic effect assays

Records management, data entry, sterile technique, troubleshooting and maintaining lab in a GMP

compliant, inspection ready state

Manufacturing Bio-Technician July 1988-September 1990

Vaccine Production

Growth and maintenance of cell lines

Prepared and monitored equipment required for vaccine production

Manufactured vaccine products utilizing aseptic technique. Prepared in-process samples for laboratory operations and preparation of final product for freezer storage

PHILADELPHIA GERIATRIC CENTER, Philadelphia, PA March 1987-July 1988

Medical Technologist

Generalist

Gained proficiency in the following areas of the clinical laboratory: Hematology, Microbiology, Automated Chemistry and Special Chemistry

Responsibilities included phlebotomy, data entry, data review, stat testing and results reporting

Specific testing performed included: CBC with differential, PT/APTT, Urinalysis, Thyroid Panel, Occult

Blood, Therapeutic Drug Monitoring, Microbiological Techniques, Bacterial Culture, Gram Stain, C. Difficile Toxin Assay, SMA24

SMITH KLINE BECKMAN CLINICAL LABORATORIES, King of Prussia, PA June 1985-March 1987

Medical Technologist

Radioimmunoassay

Gained proficiency in the following RIA assays: t3, T4, B12, Folate, Quantitative HCG, Estriol and

Estradiol

Responsibilities included sample handling, troubleshooting, data review and results reporting

EDUCATION

Bachelor of Science, Medical Technology

Bloomsburg University, Bloomsburg, Pennsylvania

ACCREDITATIONS

MT, ASCP

PROFESSIONAL MEMBERSHIPS

American Association of Clinical Pathologists

SKILLS

Microsoft Office, MIDAS, EquipNet, SDLC, Deviation Management, Adobe Acrobat, ELN, BioInventory, OpenLab,

COSMIC, RLIMS, LIMS, QE Central, myLearning, SAP, Waters Empower, Cell Culture Techniques,

Microbiological Techniques, Vaccine and Biologics Sample Characterization, Biochemistry Techniques,

Trackwise, Project Management, Teamwork, High Level Multitasking, Problem-Based Learning,

Instrumentation Trouble-Shooting, Organization, People Management, Calibration, Database Maintenance



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