Manufacturing Biotechnologist (Night Shift) - Portsmouth, NH

The Biotechnologist/Manufacturing Associate I is responsible for the manufacture of therapeutic proteins (API) under current Good Manufacturing Practices (cGMP) conditions. Level I associates are expected to execute process recipes, follow written Standard Operating Procedures (SOPs), monitor equipment and processes, independently perform laboratory tasks, including pH, conductivity testing, product sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to demonstrate a strong understanding of cGMP compliance while operating under supervision, and aseptic technique in handling of products and materials. Level II Operators may also be asked to troubleshoot equipment events, initiate deviations, review batch records and logbooks.

Key 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 documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate.

• Attain qualification for all assigned tasks and maintain individual training plan.

• Demonstrate proficiency at laboratory tasks, such as monitoring pH, conductivity, product sampling etc. May train Level 1 Associates on these tasks.

• Perform material movements, transfer materials and chemicals in, out, and 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.

Key Requirements

• High School Diploma or Equivalent minimum; AS/BS preferred;

• Preferred area of study: Science related discipline

• Working experience in manufacturing; cGMP setting preferred, and/or some experience as an Associate Level I in bio-pharma industry.

• Proven logic and decision making abilities, critical thinking skills.

• Strong written and verbal communication skills are required.

• The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. Is open to and actively seeks out feedback on their performance and translates that feedback into action.