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.
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.