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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
Professional Summary

•Scientist with 15 years of analytical science experience within the pharmaceutical industry.

Education
Bachelor of Science: Life Sciences - Chemistry, Expected in 1999
New York Institute of Technology - Old Westbury, NY
GPA:
Experience
Scientist, 04/2011 to Current
Planet PharmaClayton, NC,

•Perform analytical method development and validation testing.

•Perform various routine analytical testing assignments.

•Set up and initiate stability studies.

•Author analytical procedures, method development reports, validation protocols/reports, technical reports, and laboratory equipment procedures.

•Demonstration/familiarization of analytical methods to fellow analysts for training purposes.

•Complete all assigned training to maintain qualification to perform tasks.

•Maintain and coordinate calibration and preventive maintenance schedule for all laboratory instrumentation.

•Participated in global SOP harmonization groups.

Associate Scientist, 01/2006 to 04/2011
Planet PharmaColumbia, MD,

•Performed routine testing using a variety of analytical techniques.

•Supported method development and validation for multiple projects and dosage forms.

•Perform feasibility experiments and compiled data for project review meeting.

•Prepared data tables and authored validation sections for regulatory filings.

•Initialized in-house stability studies.

•Participated in cross-functional analytical working group meetings.

Analytical Chemist, 10/2001 to 01/2006
Entegris, Inc.Bloomington, MN,

•Perform testing/methods validation etc. on all instrumentation (UV/Vis, AA, FTIR, Dissolution apparatus, HPLC, GC).

•In-Process Dissolution testing of products.

•Performed product specific and instrument training for analysts.

•Became a versatile chromatographer while performing release and stability testing on numerous products within a group (Tests included Content Uniformity, Assay among others).

•Wrote/Revised various SOP’s, IOP’s, CP’s, and GTP’s.

•Troubleshoot Analytical Instruments such as GC/HPLC.

•Assist in Analytical Methods development via Method Transfer to Quality Labs.

•Review analytical paperwork, maintaining accordance to current GMP guidelines.

•Performed instrument qualifications along with CSV Part 11 Remediation group.

•Member of Millennium Paperless Reporting group reducing the bulk of paperwork within batch records.

Organic Preparations Supervisor, 02/2000 to 03/2001
Hampton Clarke/Veritech LaboratoriesCity, STATE,

•Supervised a group of five technicians in the preparation of samples for Gas Chromatography analysis by numerous EPA methods.

•Assisted in the preparations following set SOP's.

•Daily delegation of responsibilities from a generated back-log.

•Daily logging out of completed samples after preparation.

•Performed necessary troubleshooting and mechanical repairs within lab.

Organic Preparations Technician, 08/1999 to 02/2000
Severn-Trent LaboratoriesCity, STATE,

•Responsible for routine preparations of samples for Gas Chromatography analysis as per EPA methods (8270, 640, etc.).

•Maintained proper documentation and used required lab instrumentation in accordance to set SOP's.

Qualifications
  • Subject Matter Expert in multiple analytical techniques including HPLC, GC, Dissolution, UV/Vis Spectroscopy
  • Excellent troubleshooting skills
  • Detail oriented while ensuring project timelines are met.
  • Proficient in the analysis of multiple dosage forms with emphasis on tablets and emulsions.
Certifications

Lean Six Sigma Yellow Belt (December 2011)

Presentations

Poster Presentations

•Claire, S; “Development of an HPLC Method for the Determination of “Lyso” Degradant of Excipient Hydrogenated Phosphatidylcholine in reformulated Elocon Cream 0.1% using Charged Aerosol Detection (CAD)” – 2013 Summit Analytical Community Day


•He, H.; Zhang, F.; Claire, S.; Haug, J.; Goldfarb, D.; Verduyckt, T.;

Harris, D.; Liang, S.; and Waters, C.; "Investigation of Compound E Formation in Reformulated Elocon Cream as a function of Internal Phase pH and Raw Material (Aluminum Starch Octenylsuccinate) pH" – 2012 Merck Manufacturing Division Science and Technology Days Conference


•Goldfarb, D.; Harris, D.; Verduvckt, T.; Castermans, K.; Goor, S.; Vaes, T.; Tully, R.; Xiong, L.; Claire, S.; Henderson, A.; and Yee, O.; “Process Development in a Manufacturing Environment: Collaboration on Elocon Cream reformulation between PCT and Supply” – 2010 Science and Technology Days Innovation, Collaboration, and Compliance


•Sigvardson, K.; Claire, S.; Christopher, D.; Dey, M.; Fett, J.; Nijhuis, M.; and Wynia, G.; “A General Experimental Approach for the Separation of Method and Product Variability in Content Uniformity Test Methods” – 2009 Pharmaceutical Sciences and Drug Metabolism Science Symposium


•Drake, J.; Kachar, L.; Claire, S.; Xu, J.; and Fett J.; “NIR Method for Content Uniformity Determination of Commercial-Scale Batches Based on Laboratory-Scale Calibration Models” – 2009 Pharmaceutical Sciences and Drug Metabolism Science Symposium

Computer Skills
  • Waters Empower 2 and 3
  • Electronic Laboratory Notebook
  • Research LIMS
  • Minitab (ver. 15, 16, and 17)
  • JMP (ver. 9 and 10)
  • Microsoft Office
  • Trackwise
  • ProCal
  • UV/Vis Chemstation (version A.10.01)
Organizations

•Boy Scouts of America (1989 – 1995)

Awards and Recognition

•Merck Commercialization Award (2nd Half 2015)

•Merck Award of Excellence (2010 - 2016)

•Schering-Plough Shining Performance Appreciation Award (2004 - 2010)

•Schering-Plough Best of Everything Award (2002 and 2003)

•New York Institute of Technology - Deans List (1995 – 1999)

•Boy Scouts of America - Eagle Scout (1995)

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School Attended

  • New York Institute of Technology

Job Titles Held:

  • Scientist
  • Associate Scientist
  • Analytical Chemist
  • Organic Preparations Supervisor
  • Organic Preparations Technician

Degrees

  • Bachelor of Science

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