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Scientist - PC

Scientist - PC

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

 

Your Role:

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. Perform analysis of testing performed within the Product Characterization Laboratory.  May act as subject matter expert in bioassay development for studies performed in the Product Characterization laboratory.  Will develop/validate and perform GMP methods.

 

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:

Minimum Qualifications:

  • Ph.D. in scientific discipline with 2+ years lab work experience -OR- Master’s Degree in scientific discipline with 4+ years lab work experience -OR- Bachelor’s Degree in scientific discipline with 6+ years lab work experience
  • 1+ years of experience leading and/or supervising staff in a laboratory setting
  • 2+ years of experience in scientific discipline executing and overseeing technical projects and/or related studies

 

Preferred Qualifications:

  • Relevant working knowledge and Experience with some or all of the following technical disciplines;
    • Complement-Dependent Cytotoxicity (CDC)
    • Target Antigen Affinity and Binding
    • Antibody Dependent Cell Mediated Cytotoxicity (ADCC)
    • Antibody Dependent Cell Mediated Phagocytosis (ADCP)
  • Development and optimization of the following assays:
  • ADCC Reporter Assay F158 Variant
  • ADCC Reporter Assay V158 Variant
  • Fab Mediated Cell Based Assay
  • C1q Binding ELISA
Job Requisition ID:  187877
Location:  Rockville
Career Level:  C - Professional (1-3 years)
Working time model:  full-time


Job Segment: Scientist, Laboratory, QA, Quality Assurance, Science, Research, Quality, Technology

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