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Scientist, Product Characterization

Your Role: 


Perform analysis of testing performed within the Product Characterization Laboratory.  May act as subject matter expert in Analytical Chemistry for studies performed in the Product Characterization laboratory.  Will develop/validate and perform GMP methods.




The Scientist will oversee a wide variety of safety testing required to manufacture clinical and commercial products. The Scientist will be the primary scientific resource for a given study with the Product Characterization lab within the overall Biologics department.  The Scientist is responsible for making observations and ensuring all documentation is in compliance with procedures and regulations.




  • Provides day to day technical support to the laboratory.
  • Performs analysis and interpretation of data.
  • Prepares/ reviews protocols and final reports.
  • May serve as study director and ensures timely initiation and completion of all studies.
  • Ensures  testing  is  performed  in  accordance  with  SOPs  and  regulations  (cGMP  and  GLP)  for custom/non routine and new services.
  • Participate and/or drive assay development/ assay transfer and/or assay validation activities.
  • Justify business needs and drive implementation of new services.
  • Operates and maintains lab equipment as required by SOPs and testing procedures.
  • Responsible for resolving deviations/ completing event records.
  • Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing.
  • Maintains high level knowledge of lab procedures and assays.
  • Responsible for creating revising SOPs, laboratory records and other related documentation.
  • Coaches/ trains others on developing and enhancing day to day laboratory techniques.
  • Contributes ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment.
  • Regarded as a subject matter expert (SME)
  • Provide  technical  advice  and  support  for  internal  and  external  interactions  such  as  client  and regulatory audits/inspections, meetings, teleconferences.
  • Promote a culture of continuous improvement within Biologics; act as champion on initiatives and/or projects to drive improvement in quality and / or client service.
  • Contributes/ authors scientific publications and presents at conferences/ seminars.
  • Leads projects that cross multiple disciplines.
  • Complies with company health and safety regulations and procedures.
  • Performs other duties as assigned


Who You Are:




•   Ph.D. in scientific discipline with 2 or more years of relevant experience

•   MA/MS in scientific discipline with 4 or more years relevant experience

•   BA/BS in scientific discipline with 6 or more years relevant experience



  • Relevant working knowledge and experience in Analytical Chemistry executing and overseeing technical projects and/or related studies
  • Experience leading and/or supervising staff in a laboratory setting
  • Experience with some or all of the following technical disciplines;
    • Liquid Chromatography
    • Mass Spectrophotmetetry – performing the following tests;
      • Molecular weight
      • Peptide mapping
      • Glycan Profiling
      • N-Terminal Sequencing
    • UHPLC methods
    • Capillary Electrophoresis Methods (CE, cIEF)
Job Requisition ID:  186053
Location:  Rockville
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

Job Segment: Chemistry, Scientist, Laboratory, QA, Science, Research, Quality

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