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Principal Scientist - Product Characterization

Your Role:

The Principal Scientist is the primary scientific resource for a Product Characterization lab.  The Principal Scientist is responsible for the scientific integrity of technical work performed in Biologics, ensuring current regulatory requirements are met and the technical & regulatory needs of internal and external clients are appropriately met, effectively interpreted and then communicated to the client.  The Principal Scientist will assume all aspects of the lead scientist role in new customer assays in line with appropriate quality driven requirements and regulations. Perform analysis of testing performed within the Product Characterization Laboratory. Oversee the development services function for a specific scientific discipline(s) within Biologics. This position may have supervisory responsibilities.


Essential Job Functions:


  • Act as the technical expert for specific defined area(s) of BioReliance business.
  • Act as the lead scientist on “new customer assay” projects.
  • Act as the scientific ‘consultant’ for clients; providing technical and regulatory input into relevant programs.
  • Liaise closely with client representatives to ensure their expectations are met or exceeded.  This should include input into technical design of new custom assays and ongoing scientific and regulatory support throughout these projects / programs.
  • Champion or lead assay development/ assay transfer and/or assay validation activities.
  • Justify business needs and drive implementation of new services.
  • Participate in critical event / lab investigations within Biologics and liaise with Program Management to ensure the significance of events is actively communicated to clients.
  • Work with operational departments within area of expertise to update assays in line with the appropriate Validation Master Plan and client / regulatory expectations.
  • Lead by example, offer scientific coaching and mentoring to other staff members (training and scientific support for ongoing projects).
  • Monitor industry trends to ensure that BioReliance remains at the forefront of scientific advancements in the field of Biologics; review and recommend potential technical developments to senior / executive management.
  • Provide regular updates of technical developments, new assays, innovation within the industry to Operations teams, Support teams (as relevant), and other members of the Technical Support group.
  • 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.
  • Prepare, publish and/or present (internally and externally) scientific data, abstracts, papers, posters, etc. to advance the reputation of BioReliance within the marketplace.
  • Responsible for assay / method / process validation ensuring assays / methods / processes are maintained in a validated state within area of expertise.
  • Track and trend key assay / production parameters and recommend courses of action to address any adverse trends and / or issues that arise.
  • Provide technical advice and support for client and regulatory interactions (audits, meetings, teleconferences and inspections).
  • Support sales in the field, attend client visits with account managers and participate in company seminars as required.
  • May perform other related duties as required and / or assigned


Who You Are

Minimum Qualifications:


  • Ph.D. in scientific discipline
  • 6+ years of knowledge and experience in Analytical Chemistry executing and overseeing technical projects and/or studies
  • 3+ years of experience leading and/or supervising staff in a laboratory setting


Preferred Qualifications:

  • 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:  187875
Location:  Rockville
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Job Segment: Chemistry, Scientist, Program Manager, Laboratory, Science, Management, Research

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