Maintenance Management
Resume:
Gregory Bailey
Email: **********@********.***
Address: ** ****** ****** #*
City: Somerville
State: MA
Zip: 02145
Country: USA
Phone: 910-***-****
Skill Level: Experienced
Salary Range: $65,000
Willing to Relocate
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
Gregory Scott Bailey Jr.
55 Vernon Street #1.
Somerville, MA 02145
**********@********.***
Objective:
To obtain a position in a biotech or pharmaceutical company that will utilize my education and scientific background, as well as provide opportunities for professional development.
Qualifications:
Working knowledge of NMR spectroscopy, as well as practical usage of NMR spectrometers and their maintenance.
Routine NMR analysis of peptides and complex carbohydrates.
Trained and assisted walkup NMR users.
Experienced with both Varian and Bruker NMR software.
Experienced with both Varian and Bruker spectrometers maintenance and repairs.
Experience in performing QC/QA procedures in a laboratory setting.
Certified OSHA Emergency Response Technician.
Routine use of HPLC to determine the Titer of IgG.
Highly motivated professional with over three years experience in diagnostics providing support to clinical trials and clinical testing.
Skills: NMR spectroscopy, CD, DSC, GMP and GLP, Clinical Data Management HPLC, ELISA, MS.
Professional Experience:
Biogen Idec. Global Stability July 2012 present
QC Associate II
Review and build stability protocols in LIMs.
Create, enter and verify GMP stability tables.
Review and verify FDA response documents.
Enter and review data entered into LIMs.
Custom NMR Service April 2012 July 2012
NMR Technician
NMR spectrometer troubleshooting and maintenance for both Varian and Bruker instruments.
Momenta Pharmaceuticals Inc. Cambridge, MA 2006 2012
Senior Research Associate
Routine NMR console, magnet, and cryo-probe maintenance, troubleshooting, validation and operation for use in both a research and a GMP environment.
Reviewed and executed MNTAs SOP for the operation of MNTAs Varian and Bruker NMR spectrometers in a GMP-compliant fashion.
Collaborated with AD/QC and QA to resolve M-Enox release testing issues around the NMR determination of M-Enox 1,6-anhydro content.
Trained on GMP testing requirements to become a qualified GMP tester.
Developed and implemented NMR methods at MNTA including 1 and 2D methods to analyze and characterize MNTAs release material.
Coordinated routine and non-routine services for the companys Varian and Bruker 600MHz instrument. Coordinated with QC/ QA and vendor to complete PMs according to our policy.
Developed good working relationships with the NMR manufacturers and service technicians, which resulted in decreased response times and greater uptime for the instruments.
Worked with and assisted the installation technicians throughout the entire NMR installation and validation process by providing logistical support.
Contributed to the NMR room build out plan (space and facilities) by providing spectrometer requirements and suggestions on appropriate backups.
Conducted preliminary research to investigate higher order structure for GCFS using NMR for the glycoprotein project.
Conducted research in nearest neighbor study, methylated and acetylated GA, hydantoin and fragment mapping projects.
Kelly Scientific, Raleigh, NC 2004 2006
Clinical Data Coordinator
Performed contract work for both Quintiles and Duke Clinical Research Institute.
Participated in database audits, testing and validation. Issued and resolved DCFs.
LipoScience Inc. Raleigh, NC 2002 2004
Clinical Laboratory Scientist
Developed and implemented new NMR methods and technology for use in a highly regulated environment for clinical trials research and clinical laboratory, including the authoring and implementation of company SOPs.
Participated in the installation, qualification and maintenance of over 15 Bruker spectrometers.
Routine NMR maintenance, troubleshooting and operation for use in clinical trials testing and routine clinical testing in a CLIA certified laboratory.
Trained on the proper handling of blood, urine and stool samples.
Trained on 21 CFR and HIPAA regulations.
Worked with Clinical trials staff to coordinate instrument availability and client-specific procedures.
Research Triangle Institute RTP, NC 2001 2002
NMR Lab Research Assistant
Worked under a medicinal chemist to manage and run the NMR lab and aid in the discovery process.
Maintained two Bruker NMR spectrometers (500 MHz and 300 MHz with both a sample changer and ICONNMR).
Ran NMR samples based upon their corresponding GLP requirements
Ran MS to aid in identification
Ran ELISA to determine Protein concentration
Fraction collection using HPLC to concentrate metabolites.
Trained and assisted new routine NMR users.
Designed, ran, and helped assign 2D experiments for the structure elucidation of small molecules (HMQC, COSY, ROESY, and HSQC).
Studied the diffusion of several different polymer solutions to study the binding of nicotine.
Professional Training:
Varian Service and Maintenance Course: Dec. 2009
Troubleshooting of the RF and Digital components on the Varian VNMRS spectrometer.
Learned how to properly diagnose issues and replace multiple parts.
HAZMATEAM OSHA 29CFR1910.120q: Jan. 2008
Trained to clean up hazardous material spills.
Learned the proper use of several protective devices and clothing to insure safety.
Varian System Administration Training: Dec. 2007
VNMRJ software administration (loading and configuring).
Trained to download and install patches, configure user accounts and modify users privileges.
HIPAA Training Program: 20 Hours Complying with the Privacy Rule in Research by Medical Research Management, Inc
Clinical Research Associate Education and Training Program Conducted by Medical Research Management, Inc, an accredited provider through ACPE.
Fundamentals of Clinical Research Feb. 2005
140 hour Training Program included the following topics:
The drug research and development process, Identifying and reporting of non-serious and serious adverse events, principles of data management and query resolution, protocol development, case report form design, and informed consent writing.
Good clinical practices 21 CFR 312 IND, 21 CFR 50 Protection of Human Subjects, 21 CFR 56 IRB, 45 CFR 46, 21 CFR 54 Financial Disclosure by Clinical Investigators. International Conference on Harmonization (E6) GCP Consolidated Guideline and (E2A) Clinical Safety Data Management.
Monitoring method and responsibilities: Systematic approach to monitoring, managing essential documents and clinical trial materials. Selecting investigators and conducting pre-evaluation, study initiation, interim, and close out visits. Writing pre-visit letters, follow up letters, and site visit reports. Performed five mock site visits utilizing case studies and wrote example monitoring reports.
Bruker Service and Maintenance Course: Oct. 2003
Trouble shooting and servicing of Brukers AVANCE consoles.
Maintenance of the Bruker AVANCE console.
Education:
The University of North Carolina at Chapel Hill Dec.2000
Bachelors Degree; Chemistry
Computer Skills:
Adept at Topspin 3.0, ICON-NMR, VNMRJ, MNOVA,Chemstation, MS Excel, Word, PowerPoint, and Outlook. Proficient with both Windows and UNIX operating systems, Oracle Clinical and Clintrial. Familiarity with Laboratory Information Management (LIMS) software.
Publications:
Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System; N Engl J Med 2008; 358:2457-2467; June 5, 2008
References Available Upon Request
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