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Scientist 2 Product Characterization (Analytical Chemistry)

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:

Minimum Qualifications:

  • Ph.D. in scientific discipline (i.e. Chemistry, Biochemistry, etc.) with 2+ years of related experience in a laboratory environment – OR –
  • Master’s degree in scientific discipline (i.e. Chemistry, Biochemistry, etc.) with 4+ years of related experience in a laboratory environment – OR –
  • Bachelor’s degree in scientific discipline (i.e. Chemistry, Biochemistry, etc.) with 6+ years of related experience in a laboratory environment


Preferred Qualifications:

  • 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 Spectrophotometry – performing the following tests;
      • Molecular weight
      • Peptide mapping
      • Glycan Profiling
      • N-Terminal Sequencing
    • UHPLC methods
    • Capillary Electrophoresis Methods (CE, cIEF)


Job Requisition ID:  207016
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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