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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

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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