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Senior Scientist, Analytical Chemistry - United States  

Company managed [?] Still accepting applications

Posted on : 16 April 2017

Project Description

Responsibilities

BASIC SUMMARY:

 Assist in the development of methods for related to the testing and characterization of biotherapeutics using analytical instrumentation and methodologies.  Under minimal supervision, may be responsible for method development, client interaction, interpretation and reporting of data and regulatory compliance of assigned research projects. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

  • Perform and troubleshoot laboratory experiments, test, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics through use of analytical testing and characterization instrumentation and methodologies.
  • Perform routine testing techniques such as the following with a high degree of reliability, efficiency and accuracy:
    • Chromatographic Analyses including Process Related Residuals
    • Quantitative Monosaccharide and Sialic Acid Analysis
    • ELISA/ Immunoassay Analyses
    • Process Residual/Drug Product Excipient Analyses
    • N- Terminal Sequencing
    • Amino Acid Compositional Analysis/Extinction Coefficient Determination
  • Review, interpret, integrate and present experimental data using assistance of senior technical staff as appropriate.
  • Assist in reviewing procedures and data.
  • Generate high-quality protocols and reports in conjunction with senior research personnel.
  • Provide technical guidance to junior staff.
  • Assist in long-term projects (redesign of SOPs, STMs, basic research procedures or report formats).
  • Interact with the client regarding project design, scheduling and conduct as requested.
  • Collaborate with appropriate departments to coordinate performance of projects, discuss issues and prepare reports.
  • Attend scientific meetings, conferences and training courses to enhance job and professional skills.
  • Perform other related duties as assigned.
Qualifications

Education: Bachelor’s degree (B.A./B.S.) or equivalent in chemistry, biochemistry, analytical chemistry, biology or related discipline. Masters or PhD preferred.
Experience: 2 years’ relevant laboratory in experience in the bio/pharmaceutical industry required, with a focus on working in a GMP environment preferred.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Certification/Licensure: None.
Other:  Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and Good Manufacturing Practices (GMPs). Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, etc. and with standard laboratory calculations and interpretation. Previous experience in a range of HPLC and other protein analysis methods are required. Knowledge and experience with CE and ELISA is a plus.

Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet