Teva Biologics is currently seeking a Lab Operations and Compliance Manager to join our Laboratory Operations and Compliance, Biologics, Assays and Technology (GBT) team. 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. The position requires knowledge and proficiency in Sample Management using Watson LIMS and experience in immunogenicity and/or PK/PD/Biomarker Assays, 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.
• Performs thorough review of data and supporting documentation in support of immunogenicity and PK/PD/Biomarker method validation and studies.
• Trains and develops group members to ensure compliance, data quality and integrity.
• Leads streamlining and improvement efforts in sample tracking and management using Watson LIMS
• Leads interaction/meetings with QA regarding data quality and integrity.
• Participates in preparation and/or review of SOPs
• Leads streamlining and harmonization in working processes, and quality/compliance efforts
• Participates in regulatory training, SOP training, general laboratory/safety training
M.S. in a related field with a minimum of 10 years, or B.S. in a related field with a minimum of 12 years of bioanalytical experience in pharmaceutical, biotechnology, and/or CRO industry.
Previous experience in Data Review (QC) in support of large molecule assays required
Experience and proficiency in Watson LIMS.
Proficiency in Microsoft Office and SoftMax.
Knowledge on data integrity and regulatory requirements.
The candidate must be able to work collaboratively in a diverse, fast-paced environment with ability to multi-task.
Good communication, interpersonal, and management skills are required.
Key words: Watson LIMS, Data Review, Quality Check, Large Molecule, Biologic