Cell & Gene Therapy Manufacturing Technician I

Genezenlabs; Lexington (MA); On-site; USD 37,195 - 45,460; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match

Health, dental and vision plans

Flexible paid time off

Job summary

Genezen is seeking a Manufacturing Technician I to play a hands-on role in the production of clinical and commercial cell and gene therapy products at our Lexington, MA facility. You will perform routine and non-routine manufacturing operations in a cGMP environment, ensuring accurate documentation and compliance.

You will collaborate with MSAT, QC, QA, Engineering and Validation teams to ensure safe, compliant and high-quality manufacturing, support equipment changeovers, training and GDP

Qualifications

• High school diploma or higher; Life Sciences/Engineering preferred.
• Experience with GMP documentation and batch records is a plus.
• Experience with manufacturing documentation and GDP concepts recommended.

Responsibilities

• Execute routine and non-routine production activities according to the manufacturing schedule.
• Follow cGMP requirements, SOPs, batch records, and solution preparation records.
• Use ERP system to execute transactions accurately and in real-time.
• Demonstrate and apply aseptic processing techniques.
• Operate in production areas such as Pre-culture, USP, DSP, buffer preparation, and Fill Finish.
• Perform troubleshooting activities within established procedures.
• Participate in shift handoffs and communicate critical production information.
• Support off-shift, overtime, and holiday production activities as required.

Skills

Attention to detail

Regulatory compliance

Documentation skills

Good communication

GDP/GMP knowledge

Cross-functional collaboration

Education

High School, Associates, or Bachelor's Degree (Life Sciences/Engineering)

Tools

ERP system

Job description

Genezen is seeking a Manufacturing Technician I to play a hands-on role in the production of clinical and commercial cell and gene therapy products at our Lexington, MA facility. You will perform routine and non-routine manufacturing operations in a cGMP environment, ensuring accurate documentation and compliance.

You will collaborate with MSAT, QC, QA, Engineering and Validation teams to ensure safe, compliant and high-quality manufacturing, support equipment changeovers, training and GDP