Scientific Associate (Associate Expert Potency)

Spectraforce Technologies, Inc.; East Hanover (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Scientific Associate (Associate Expert Potency) in East Hanover, NJ to support development activities for gene therapy analytics. The role involves performing and qualifying cell-based potency assays and contributing to cross-functional processes for continuous improvement.

The candidate will work onsite in a fast-paced team, handling sample testing, data analysis, and regulatory documentation while ensuring compliance with GxP and safety requirements.

Qualifications

• MS in Biology, Biochemistry, Bioengineering or related field with 0–2 years’ research, or BS with 4 years’ equivalent.
• Basic understanding of cell biology and protein chemistry.
• Experience with cell culture and aseptic techniques required.
• Exposure to bioassays and analyzing multiple assay platforms is expected.
• Strong communication and ability to work in a fast-paced team.

Responsibilities

• Participate in method development and qualification of cell-based potency assays for AAV and LVV vectors.
• Support phase-appropriate bioassay development and data analysis for regulatory filings.
• Manage critical reagents, in-process samples, and assay transfers to QC/ CRO labs.
• Document protocols, summaries, and test results with clear records.
• Maintain inventory and support routine lab activities.

Skills

Communication skills

Team collaboration

Detail oriented

Fast-paced work

GxP familiarity

Education

MS in Biology/Biochemistry/Bioengineering

BS with 4 years equivalent

Tools

ELISA

MSD

High-content imaging

qPCR

dPCR

Job description

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.