Scientific Associate

Merck & Co.; East Hanover (NJ); On-site; USD 41,000 - 55,000; Full time

Job summary

Merck & Co. in East Hanover, NJ, seeks a Scientific Associate (Associate Expert Potency) to support development of analytical methods for gene therapy products.

The role focuses on cell-based assays to characterize potency and lot disposition, with cross-functional collaboration for process improvements. The successful candidate will perform routine testing, contribute to method development, and document experiments in a GxP environment, preparing data for regulatory filings.

Qualifications

• MS in Biology, Biochemistry, Bioengineering or related field; 0–2 years experience, OR BS with 4 years of equivalent education/experience.
• 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 ELISA, MSD, high-content imaging, or luminescence/fluorescence assays is desired.
• GxP laboratory experience is preferred but not required.

Responsibilities

• Participate in method development and qualification of cell-based potency assays for in-process and DP lot release.
• Perform experiments under supervision to support development and characterization for regulatory filings.
• Support reagent management, sample handling, and assay transfers to QC/ CRO labs.
• Document protocols, summaries, and reports; maintain records of experiments.
• Monitor inventory levels for laboratory supplies and safety equipment.

Skills

Cell culture

Bioassays

Data analysis

Laboratory teamwork

Education

MS in Biology/Biochemistry/Bioengineering or related

BS with 4 years of equivalent education/experience

Tools

ELISA

MSD

High-content imaging

qPCR

Job description

Job Title: Scientific Associate (Associate Expert Potency)

Location: East Hanover, Onsite

Duration: 18 months

Pay Rate: ***/hr - ***/hr

Job Description

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. 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.

About the Role:
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.

Essential Requirements:

• 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.
• Note:
• 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.