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Sr. Associate Scientist, Product Characterization

Your Role:

Perform assays/ testing for a laboratory within Biologics.  This position may have supervisory responsibilities for associate scientists I and II

 

PURPOSE OF THE POSITION

 

The Senior Associate Scientist will perform safety testing required to manufacture clinical and commercial products. The Senior Associate Scientist is required to make scientific observations, maintain detailed workbooks/ documentation and ensure all documentation fulfills generally accepted professional/industry standards. Requirements also include maintaining a thorough understanding of MilliporeSigma services, technical principles and applications 

 

ESSENTIAL JOB FUNCTIONS

 

  • Act as subject matter expert (SME) for specific defined area(s) of MilliporeSigma business.
  • Applies laboratory techniques and skills to complete experiments designed to address a variety of specific problems.
  • Independently applies basic scientific principles in the design of experiments and the development of assays.
  • Performs testing in accordance with SOPs and regulations (cGMP and GLP) for custom/ non-routine and new services.
  • Maintains complete and comprehensive records for study integrity.
  • Makes detailed observations, documents results and performs data analysis.
  • Operates and maintains lab equipment as required by SOPs and testing procedures.
  • Utilizes applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc.).
  • Utilizes problem solving/ trouble shooting skills.
  • Communicates deviations/ events, progress and interim results to Study Management.
  • Leads the completion of 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 a working knowledge of lab procedures and assays.
  • Creates/ revises SOPs, laboratory records and other related documentation as assigned.
  • Writes technical reports for internal use and collaborates on papers for external use.
  • Performs training of laboratory personnel as needed/ assigned
  • May serve as team lead.
  • Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment.
  • Acts as key driver/ champion on project teams.
  • Complies with company health and safety regulations and procedures.
  • Performs other duties as assigned.

     

Who You Are:

 

Education (minimum requirements):

  • Ph.D. in scientific discipline with 1 or more years relevant experience
  • MA/MS in scientific discipline with 2 or more years relevant experience
  • BA/BS in scientific discipline with 5 or more years relevant experience
  • Or 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:  186054
Location:  Rockville
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


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