Scientific Associate (Associate Expert Potency)
•6 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | East Hanover, New Jersey |
About this job
Position Title: Scientific Associate (Associate Expert Potency)
Work Location: East Hanover, NJ 07936
Assignment Duration: 18 Months
Work Arrangement: Onsite
Position Summary:
Background & Context:
Key Responsibilities:
Qualification & Experience:
Working Conditions & Physical Demands:
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.
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