Scientific Associate (Associate Expert Potency)

Position Title Scientific Associate (Associate Expert Potency) Work Location East Hanover, NJ 07936 Assignment Duration 18 Months Work Arrangement Onsite Position Summary As a key member of the Analytical Development team, this individual will support developmental activities to aid in delivering gene therapy to patients. The successful candidate will support technical and development projects designed to characterize gene therapy products through an assortment of analytical methods. Background & Context This role will also contribute to cross-functional activities including monitoring and characterizing of processes and products to identify opportunities for continuous improvement. Growth mentality and passion to serve patients, his/her technical team and development programs are a must. The Associate Expert, Science & Technology (Research associate) performs routine testing and to develop bioassays suitable for lot disposition and characterization of gene therapy drug substances and drug products. Key Responsibilities Participate in method development and qualification of cell-based potency assays suitable for both in-process and drug product (DP) lot release and quality attribute assessment for AAV and LVV viral vectors. Execute experiments under supervision to support development and optimizations for phase-appropriate bioassay and characterizations for drug regulatory filings. Be responsible for critical solution preparations under both research and GxP environment. Participate in cross-functional activities including critical reagent management, in-process sample handling, process development analytical supports, and assay method transfers to Quality Control/Clinical Research Organization laboratories. Perform sample testing and data analysis with developed analytical methods. Document experimental protocols, summaries, and reports. Maintain experiment records. Support critical laboratory activities including monitoring inventory levels for laboratory supplies. Qualification & Experience MS in Biology, Biochemistry, Bioengineering or related scientific discipline with 0-2 years research experience in area or BS with 4 years of equivalent education/experience may be accepted. Basic understanding of cell biology, protein biochemistry, and molecular biology. Experience with cell culture and aseptic technique is required. Experience with bioassays/bioanalytical research using platforms such as ELISA, MSD, high-content imaging, and luminescence/fluorescence assays, qPCR/dPCR is desired, but not required. Previous experience in GxP laboratory is desired, but not required. Quick learner, highly motivated, hard-working and detail oriented. Strong ability to work in a fast-paced team environment with highly goal-oriented approaches and to prioritize work from multiple projects with can-do attitude is required. Excellent written and verbal communication skills. Working Conditions & Physical Demands Standard laboratory PPE is required, including safety glasses, a lab coat, and appropriate gloves. Additional PPE may be required based on task-specific risk assessments, such as respiratory protection, face shield, cryogenic gloves, or hearing protection. Access to and safe operation of laboratory analytical equipment is permitted only after completion of applicable training and in accordance with SOP requirements. Must comply with all the organization HSE, data integrity, and quality requirements. Completion of site-specific safety onboarding and required training is required before laboratory access is granted. Must adhere to laboratory SOPs, risk assessments, safe work practices, and incident reporting procedures. Proper use of PPE and safe handling of biological materials, chemicals, and laboratory equipment is required. Must comply with applicable documentation practices, electronic systems, and data integrity requirements. #J-18808-Ljbffr Spectraforce Technologies, Inc.