Cell Therapy GMP Manufacturing Specialist

ClinLab Solutions Group; New Jersey; On-site; USD 50,000 - 70,000; Full time

Job summary

ClinLab Solutions Group is seeking a detail-oriented professional to support cell therapy production in a regulated cleanroom environment. This role requires strong aseptic technique, adaptability, and a commitment to quality standards to ensure the consistent delivery of high-standard therapeutic products.

The successful candidate will conduct aseptic manufacturing operations in a GMP-compliant facility, document processes with traceability, and collaborate cross-functionally to drive

Qualifications

• Bachelor's degree in Biology, Biotechnology, or related field preferred; equivalent experience considered.
• 0–3 years GMP manufacturing experience, ideally in cell therapy or biologics.
• Knowledge of aseptic technique, contamination control, and cleanroom operations.
• Proficiency in basic mathematical concepts and data recording.

Responsibilities

• Conduct aseptic manufacturing operations in a cleanroom per cGMP and safety protocols.
• Execute cell therapy manufacturing procedures, including cell culture, formulation, and cryopreservation.
• Operate, calibrate, and maintain manufacturing equipment.
• Document production processes and maintain traceability.
• Escalate deviations and participate in investigations.
• Collaborate with cross-functional teams to drive continuous improvement.
• Perform cleanroom maintenance, environmental monitoring, and 5S organization.
• Assist in training, audits, validation activities, and SOP/batch record reviews.

Skills

Aseptic technique

Attention to detail

Quality standards

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree in Biology/Biotechnology

Tools

Electronic batch record systems

Job description

ClinLab Solutions Group is seeking a detail-oriented professional to support cell therapy production in a regulated cleanroom environment. This role requires strong aseptic technique, adaptability, and a commitment to quality standards to ensure the consistent delivery of high-standard therapeutic products.

The successful candidate will conduct aseptic manufacturing operations in a GMP-compliant facility, document processes with traceability, and collaborate cross-functionally to drive