Manufacturing Biotechnologist 1

Katalyst CRO; Portsmouth (NH); On-site; USD 40,000 - 64,000; Full time

Job summary

Katalyst CRO is seeking an Manufacturing Associate Level I in New Hampshire. The role involves manufacturing therapeutic proteins under cGMP, executing process recipes, adhering to SOPs, monitoring equipment, and performing basic lab tasks with supervision.

You will gain training under supervision, demonstrate aseptic technique, and contribute to GMP/GDP documentation. The position supports routine production tasks and collaborative projects.

Qualifications

• Entry level role with 0–4 years of experience.
• Proven logic and decision making abilities and critical thinking required.
• Strong written and verbal communication skills are required.

Responsibilities

• Set up, operate equipment, monitor production processes (CIP/SIP) and report production in GMP/GDP-compliant records.
• Attain qualification for all tasks and maintain training plans.
• Perform basic laboratory tasks (pH, conductivity, sample testing).
• Move materials, transfer raw materials and chemicals across production areas.
• Maintain facility/equipment through routine cleaning, sanitization; support 6S programs.
• Attend shift exchanges/meetings and participate in projects via email.
• Perform other duties as assigned.

Skills

Critical thinking

Written communication

Verbal communication

Attention to detail

Education

High School Diploma or Equivalent

Job description

Summary

The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.
• Attain qualification for all assigned tasks and maintain individual training plan.
• Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.
• Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs.
• Administrative tasks attending shift exchange, meetings, sending/receiving emails, participating in projects.
• Perform other duties as assigned.

Summary

The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

Job Description (Key Accountabilities)

• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.
• Attain qualification for all assigned tasks and maintain individual training plan.
• Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.
• Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs.
• Administrative tasks attending shift exchange, meetings, sending/receiving emails, participating in projects.
• Perform other duties as assigned.

Education

• High School Diploma or Equivalent

Work Experience

• Entry Level - 0-4 years.
• Proven logic and decision making abilities, critical thinking skills.
• Strong written and verbal communication skills are required.