Position Title:

Manufacturing Biotechnologist 1

Work Location:

101 International Drive, Portsmouth, New Hampshire 03801

Assignment Duration:

12 months

Work Schedule:

The shift schedule is from 7am-7pm, on a rotational schedule every other week: Week 1:

M/T/F/SAT/SUN

; Week 2: W/TH. Shift differentials are included for weekends worked. Initial 2 week training period on day shift Monday-Friday upon hire for new hires.

Work Arrangement:

Onsite Position Summary:

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.

Background & Context:

Supports manufacture of therapeutic proteins (API) under cGMP conditions for The Organization.

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.

Qualification & Experience:

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.

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