Biotech Manufacturing Associate - Cleanroom/GMP

Katalyst CRO; Portsmouth (NH); On-site; USD 42,000 - 54,000; Full time

Job summary

Katalyst CRO in Portsmouth, NH seeks a Manufacturing Associate to support production of therapeutic proteins in a cGMP cleanroom. You will execute process steps, operate equipment, and perform basic lab tasks while following SOPs and GMP/GDP guidelines.

This role requires willingness to work shifts, maintain meticulous documentation, and participate in handovers and project activities. A life sciences associate degree or relevant manufacturing experience is preferred.

Qualifications

• Associate degree in Life Sciences or equivalent preferred.
• Experience in manufacturing/biotech environment a plus.
• Familiarity with SOPs, GMP/GDP, and cleanroom practices preferred.

Responsibilities

• Execute manufacturing process steps and follow SOPs, batch records, and GMP/GDP guidelines.
• Set up, operate, and monitor CIP/SIP systems.
• Perform basic lab tasks: pH, conductivity, sampling, and product testing.
• Handle material movements: raw materials, chemicals, and components.
• Maintain equipment and facility through routine cleaning and sanitization (6S).
• Demonstrate aseptic technique and cleanroom gowning.
• Complete required training and maintain qualification for assigned tasks.
• Participate in shift handovers, meetings, emails, and project activities.
• Perform other duties as assigned.

Skills

SOP compliance

GMP/GDP knowledge

Lab skills

Cleanroom gowning

Documentation accuracy

Shift work

Computer literacy

Troubleshooting

Education

Associate degree Life Sciences

Relevant manufacturing experience

Tools

Electronic documentation

Automated systems

Job description

Katalyst CRO in Portsmouth, NH seeks a Manufacturing Associate to support production of therapeutic proteins in a cGMP cleanroom. You will execute process steps, operate equipment, and perform basic lab tasks while following SOPs and GMP/GDP guidelines.

This role requires willingness to work shifts, maintain meticulous documentation, and participate in handovers and project activities. A life sciences associate degree or relevant manufacturing experience is preferred.