Scientific Associate; Associate Expert Potency

Job Title:
Scientific Associate (Associate Expert Potency)
Location:
East Hanover, NJ
Duration: 18 months

• 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.
• 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.

• 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.
• 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.

• 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 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.