Teva Pharmaceuticals USA, Inc.

Senior Research Associate

US-PA-West Chester
Requisition #
17-20202
# Positions
1
Experience (Years)
4
Category
Research & Development - Biopharmaceutics

Overview

Research Associate.  This is a Quality Check position in Laboratory Operations and Compliance

 

Position: Research Associate

We are seeking a highly motivated individual with experience in supporting pre-clinical (GLP) and clinical regulated studies.  The position will focus on review of data generated from validation and sample analyses of biologics (large molecules) to ensure data quality and integrity.  You will be a member of Biologics, Assays and Technology, which plays a critical role in development of biological therapeutics from early stage research, IND enabling GLP studies, clinical trials through BLA submission and post marketing support.

 

 

 

 

 

Responsibilities

Responsibilities:

  • Performs thorough review of data and supporting documentation in support of immunogenicity and PK/PD/Biomarker method validation and studies.
  • Attends regulatory training, SOP training, general laboratory/safety training
  • Assist in sample tracking and management in Watson LIMS
  • Participate in interaction/meetings with QA regarding data review schedules
  • Assist with documentation and record management
  • Ensure compliance, data quality and integrity

 

Qualifications

M.S. in a related field with a minimum of 1 year or a B.S. in a related field with a minimum of 3 years of bioanalytical experience in pharmaceutical, biotechnology, and/or CRO industry.  Previous experience in Data Review (QC) in support of large molecule assays (PK, PD and ADA) is required. Proficiency in Microsoft Office, SoftMax and Watson LIMS, and knowledge on data integrity and regulatory requirements are expected.  The candidate must be able to work collaboratively in a diverse, fast-paced environment with ability to multi-task. Good communication and interpersonal skills are required.

 

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