Posted to MedZilla on 12/16/2017


ProClinical

United States, Scientist I - Analytical Development - SPR SC_AS_13667-MZ


 
 

ProClinical is recruiting for a newly vacant, exciting position for Scientist I – Analytical Development Department at a top vaccine company based in Gaithersburg, MD. Our client is committed to fostering a collaborative internal environment that provides ample opportunity for personal and professional achievement, while maintaining an adequate work-life balance. The qualified candidate for Scientist I should have extensive experience with label-free binding assays such as Surface Plasmon Resonance (SPR) and be familiar with immunoassays such as ELISA for testing bioactivity of proteins or vaccine products. The position requires initiation and involvement in the development and qualification/validation of quantitative and kinetic immunoassays for vaccine products. The ideal candidate will make detailed observations, analyze data, interpret results, write qualification/validation reports and SOPs, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments. Additionally, the candidate will receive general instructions from a supervisor and will work independently, as well as collaborate with other team members and other groups.

Responsibilities

  • Assay development for analysis and characterization of particles.
  • Apply new cutting-edge technologies for in-process testing and biological product characterization.
  • Develop immunoassays for nanoparticle-related products.
  • Support discovery testing needs for projects in the pipeline.
  • Perform method qualification/validation, and method transfer to other departments (e.g. QC).
  • Thoroughly analyze results and methods, solve analytical problems, and troubleshoot assays.
  • Maintain effective communication with process development, formulation, QC, discovery, and clinical groups.
  • Write, review, and edit of standard operating procedures and qualification/validation reports.
  • Prepare technical reports and scientific journal publications and presentations. Provide selected sections for CMC regulatory filing.
  • Present scientific findings at internal meetings and external conferences.

Skills And Requirements

  • Master’s degree with 5+ years relevant experience, or Ph.D. with 2+ years relevant experience.
  • Excellent analytical skills.
  • Experience with SPR, preferably Biacore or Octet required.
  • Excellent record-keeping abilities.
  • Ability to work effectively in a cross-functional environment.
  • Ability to prepare technical reports and presentations.
  • Understanding of GMP requirements and other FDA regulatory requirements associated with analytical testing of vaccine products.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Andrew Shen at (+1) 6463671089 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies

Please visit our website at www.proclinical.com

 
 


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