Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000,
To obtain employment as an Associate Scientist within a progressive pharmaceutical company that will allow me to utilize my skills, knowledge, and teamwork experience in regulatory operations. Determined to build on process knowledge while continuing to learn, & work hard; motivated to do whatever it takes to get the job done efficiently and properly. These things include paying attention to detail, organizational skills, interpersonal skills, critical thinking and troubleshooting skills to obtain day to day results. I will also use good communication skills to resolve any issues that may occur; able to maintain a cool demeanor during heated or challenging circumstances. Very eager to learn and work on projects as necessary. I am able to perform GLP, CGMP, QC, microbiology, and molecular biology assays. I am proficient in my understanding of Phase 1-3 clinical trials. I am also a seasoned nurse able to work with doctors and patients well. I possess a great understanding and skill of medical terminology, monitoring of side effects of medications, documentation in charts, QA and QI assessments, etc. I also have an excellent understanding of pathophysiology and the disease process. I am willing to work overtime if needed and weekends. RTP, NC Contract Manufacturing Science Associate/ Manufacturing Associate Proficient in operating and understanding of cGMP, GMP , GLP compliance with FDA, traceability, area safety, and documentation in real time Knowledge and experience with Class A, Class B , Class C classified areas (currently working in Class B classified area)/ experience gowning in areas Daily to weekly Bioburden Testing, Endotoxin Testing,TOC, Conductivity, Validation Test, PH, Osmoality, Aseptic Testing and Technique , Spectrophotometry, Dilutions, Growth Promotion Testing of Product and Equipment Evaluation of batch records prior to sending to QA and QC Familiar with Lean Six Sigma Experience training new employees on operations of process, CGMp, and equipment in area/ safety protocol Ability to execute manufacturing processes, while utilizing SOPs, batch records, and assigned equipment(ex. Delta V) Execute review of SLRs, batch records, and other important documentation Extensive work on process unit operations(pre/post downstream processes to include making buffers, autoclaving, Column Chromatography, building tank, instrumentation, troubleshooting, validation protocols, and hold studies, sampling/testing during process, serial dilutions, pipetting, aseptic technique, spectrophotometry, environmental monitoring during bottling, Able to use Excel, Lims, PowerPoint, Delta V Maintaining and ordering inventory/ weighing and dispensing components (worked in dispensary a little)
  • Cells, Microbiology, Anatomy & Physiology, Organic Chemistry 1and 2 with LAB, Scientific Writing, Biochemistry Lecture
  • and Lab, Immunology & Virology, Bioanalytical Chemistry, Bioprocessing & Cell Culture & Lab, Assay Design, Bioethics, Overview of Drug
  • Industry, FDA-Regulations, Quality Assurance, GMP Training, Intellectual Properties & Patent Laws, Teamwork Environment, Microsoft Excel,
  • Microsoft Word, Microsoft PowerPoint
  • Laboratory Techniques & Skills Learned
  • Environmental Monitoring,& sampling, Routine Clean Monitoring and sampling, Aseptic Technique, Elisa, Alpha Screening,
  • Immunohistochemistry, PCR, Inoculation of Bacteria, Harvesting Bacteria Cells, Inoculation of Bacteria with PET/15 LDH, Protein Purification,
  • Streak Plates, Autoclaving, Shake Flask Cultures, Large Scale Fermentation, EColi Metabolism, Inoculation & Growth Fermenter Design, Water
  • Filtration, TOC Testing, LAL, Chlorine Testing, Media Challenge, Bioburden, RODAC, Pharmaceutical WFI Water Collecting, Transformation,
  • PCR, Conductivity, Osmolality, PH, Gel Electrophoresis, spectrophotometry, plant tissue cultures, Assay validation, UV/Vis preuse /post operation,
  • Western, Northern, and Southern Blotting, HPLC, Refractometer, Fluorometer, Thin layer Chromatography, Ion Exchange Chromatography,
  • Affinity Chromatography, Hydrophobic Interaction Chromatography, Viral Inactivation and Neutralization, sub cloning of DNA, centrifuging,
  • sanitizing of WFI lines and headers, writing deviatiations, writing CAPAs, troubleshooting equipment, , cell viability testing, Nanodrop testing ,
  • assembly of tanks and BPC bags, sparging argon, ect
01/2011 to Quality Assurance IPT Coordinator/ Quality Laboratory Intern Dupont De Nemours Inc. | Saginaw, MI,
  • Actively participated as a member of the VMF101/102 Integrated Process Team (IPT) and engaged in Environmental Monitoring activities in support of VARIVAX® PU production.
  • Assisted with Environmental Monitoring testing of Grade C classified areas and qualified utilities to include: viable air, non-viable air, microbial surface sampling, and pharmaceutical water collection.
  • Assisted with Quality Microbiological Laboratory activities such as: endotoxin (LAL), water filtration, pre-filtration Bioburden testing of culture media, microbial plate reading, TOC, and pre-qualified validation studies.
  • Independently identified and tagged critical Environmental Monitoring sites in VMF102 for Clean Dry Air (CDA), Nitrogen, Argon, Water for Injection (WFI) and Clean Steam (CS).
01/2007 to 07/2013 Research Assistant Northwest Hospital | Sand, WA,
  • Experience with Affinity Chromatography, Ion Exchange Chromatography, Thin layer Chromatography, Hydrophobic Interaction Chromatography Experience working with the following during process to include PH up or down, Viral Inactivation and Neutralization, HETP, AF, SBOl trending, collection of Eluate, building BPC bags, pre /post cleaning and set up of Skids and columns, assemble and disassemble of columns, column flow, correct use of valves and filters during operation, monitoring pressure Worked with Tech Transfer/ rewriting of protocols and SOPs/troubleshooting of issues with product, cause of deviations, validation and hold studies, (example resins not working efficiently , integrity filters being clogged, trying new agar, etc.) , Aseptic Technique, titrations, microbiology techniques), while working in manufacturing science department.
  • Durham County Detention Facility (Nurse) January 13th.
01/2000 to 01/1 Licensed Practical Nurse Biogen Idec Kelly Services | City, STATE,
  • May20th, 2013 - 23December14.
Expected in May 12th, 2009 Bachelor of Science | Pharmaceutical Science Biology and Chemistry North Carolina Central University, Durham, North Carolina GPA: December 8th, 2012 Cum laude GPA: 3.5
Department of Pharmaceutical Science/Biology Biomanufacturing Research Institute Technology Enterprise Pharmaceutical Science Biology and Chemistry December 8th, 2012 Cum laude GPA: 3.5
Expected in June Associate of Science Degree (AS) & Associate | General Education Durham Technical Community College, Durham, North Carolina GPA: GPA: 3.7
General Education GPA: 3.7
Expected in 2013 | International Society of Pharmaceutical Engineers North Carolina Central University North Carolina Central University, , GPA:
Expected in 2011 | North Carolina Central University, , GPA: Dean's List Piedmont Community College 2007,2008,2009 Publication Coauthor of Downstream Processing
Dean's List Piedmont Community College 2007,2008,2009 Publication Coauthor of Downstream Processing
Expected in 2009 January 11th, 2007- May9th | Piedmont Community College, Roxboro, North Carolina GPA:
Bilingual in Spanish can speak, read and write Spanish)
Alpha, assembly, Agency, C, Oral, CPR, Critical thinking, documentation, Elisa, GMP, HPLC, notes, materials, medical terminology, Microsoft Excel, Excel, Exchange, Microsoft PowerPoint, Microsoft Word, Natural, Enterprise, Nursing, PCR, policies, progress, protocols, Quality, QA, Quality Assurance, reading, read, recording, reporting, Research, Scientific Writing, seminars, Southern Blotting, Spanish, Teamwork, TOC, translation, troubleshooting, utilities, UV, validation, written
Additional Information
  • Accolades/Extracurricular Activities BRITE Scholarship Award 2009-2011 Who's Who National for academic achievement Award Spring 2009 Phi Theta Kappa Award, Vice President 2008-2009

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School Attended

  • North Carolina Central University
  • Durham Technical Community College
  • International Society of Pharmaceutical Engineers North Carolina Central University North Carolina Central University
  • North Carolina Central University
  • Piedmont Community College

Job Titles Held:

  • Quality Assurance IPT Coordinator/ Quality Laboratory Intern
  • Research Assistant
  • Licensed Practical Nurse


  • Bachelor of Science
  • Associate of Science Degree (AS) & Associate
  • January 11th, 2007- May9th

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