*** Biologics Development is seeking a highly motivated Research Associate to join our team in advancing gene therapy and monoclonal antibody platforms. This position is within Analytical Development, a group responsible for the development, qualification, and transfer of analytical methods used for characterization of protein and gene therapy candidates in early stage development (Phase I/II). In addition, the group is responsible for cGMP release and stability testing of clinical trial materials.
The Research Associate will work under active supervision, and participate in lab activities to support testing and characterization of gene therapy, antibody, and/or enzyme products. The candidate may work with a variety of bioanalytical assays such as protein separations (CE and HPLC), cell based assays, binding assays, and mass spectrometry-based assays, and may perform method development in a limited capacity. Key expectations and core training will include accuracy in sample preparation, instrument setup, lab notebook maintenance, and ability to function within a GMP compliant environment. This is a one year contact position and may be extended for another year.
Familiar with capillary electrophoresis (CE-SDS, cIEF, CZE) and HPLC for biologics separation. Hand-on experience on a variety of bioassays is preferred.
Prior knowledge or experience on viral-based gene therapy products and/or monoclonal antibodies is preferred.
Understanding of assay method development, qualification and validation is a plus.
The capability of following cGMP compliance requirements and excellent organizational skills.
A strong ability to work both independently or in cross-functional teams and an ability to meet timelines efficiently and productively.
Proven ability to work with a high level of integrity, accuracy, and attention to detail.
Source: Job Diva – Job Listing