Manufacturing Associate

Katalyst CRO; Portsmouth (NH); On-site; USD 40,000 - 60,000; Full time

Job summary

A leading company specializing in therapeutic proteins is seeking a Manufacturing Associate. The role involves operating equipment, following rigorous procedures in a cleanroom environment, and ensuring compliance with good manufacturing practices. Ideal candidates have a background in science and prior experience in sterile settings.

Qualifications

• Experience in cleanroom or sterile settings is preferred.
• Ability to follow documentation procedures in a regulated environment.
• Prior experience in manufacturing or cGMP is ideal.

Responsibilities

• Set up and operate equipment in a cleanroom environment.
• Maintain cleanliness of facilities and equipment.
• Transfer raw materials and perform routine sanitization tasks.

Skills

Critical Thinking

Aseptic Techniques

Documentation Procedures

Education

High School Diploma

Bachelor's in Science related field

Job description

Job Description

The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. 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 products and materials.

Responsibilities

• 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 an individual training plan.
• Perform material movements, transfer raw materials and chemicals into, out of, across the production areas.
• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs.
• Must be willing to gown and work in a "clean room " environment.
• Administrative tasks attending shift exchange, meetings, sending/receiving emails, participating in projects.
• Perform other duties as assigned.
  
  

Requirements:

• High School Diploma or equivalent experience minimum with an AS/BS preferred
• Preferred area of study: Science related field, degrees in Genetics are relevant.
• Prior work experience in a cleanroom, laboratory, or another sterile setting is preferred.
• Prior experience with Aseptic Techniques and gowning procedures is preferred.
• Working experience in manufacturing; cGMP setting preferred. The ideal candidate will have experience within the Cell and Gene Therapy field.
• Able to follow documentation procedures for day-to-day tasks in a regulated industry.
• Proven logic and decision-making abilities, critical thinking skills.
• Strong written and verbal communication skills
  
  

Note:

• Days - 12-hour shifts - days 7am 7pm.
• Night shift 7 pm - 7 am, 12hr shift.