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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.

 

PURPOSE OF THE POSITION

 

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.

 

ESSENTIAL JOB FUNCTIONS

 

  • 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:

 

Education:

 

•   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

 

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


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