cGMP Bioprocess Manufacturing Associate (API)

Job Description

Job DescriptioncGMP Bioprocess Manufacturing Associate (API)

Location: Portsmouth, NH (Onsite)

About the Role

Join a biopharma manufacturing team producing therapeutic protein active pharmaceutical ingredients (API) under cGMP. In this entry-level, hands-on role, you will learn to execute batch recipes, follow SOPs with precision, and practice aseptic technique while working under close supervision. You will support both upstream and downstream operations, monitor equipment and processes, and keep our cleanrooms inspection-ready through routine sanitization.

A Day in the Life

You arrive to gown up, review batch records, and prepare equipment. You’ll set up unit operations, execute clean-in-place (CIP) and steam-in-place (SIP) cycles, and document every step using good documentation practices (GDP). Throughout the shift, you collect samples, check pH and conductivity, transfer materials safely, and keep the area organized to 6S standards. You wrap up with a thorough shift handoff and capture updates in electronic and paper systems.

How your time is typically spent

• 40%: Set up, run, and monitor production equipment and processes; perform CIP/SIP; complete electronic and paper documentation per cGMP/GDP; review records as appropriate.
• 20%: Train and qualify on assigned tasks; maintain an active individual training plan.
• 10%: Perform basic lab activities: sampling; pH and conductivity checks; routine product tests.
• 10%: Execute material movements—receive, stage, and transfer raw materials and chemicals safely across production areas.
• 10%: Clean and sanitize equipment and facility spaces; contribute to 6S initiatives.
• 10%: Administrative work: shift exchanges, meetings, email communications, project participation, and other duties as assigned.

Schedule and Pay

• Night Shift Pay: $27/hr on W2; overtime every second week for 20 hrs at $40/hr.
• Day Shift Pay: $23/hr on W2; overtime every second week for 20 hrs at $34/hr.
• Rotating pattern: On alternating weeks, you work five 12-hour shifts (60 hours total), with 20 hours paid at 1.5x. The other week, you work only two 12-hour shifts—enjoying five days off that week.

What You’ll Learn

• Executing process recipes and handling batch documentation in compliance with cGMP and GDP.
• Aseptic technique for handling products and materials under supervision.
• Operation and monitoring of bioprocess equipment and control systems.

Qualifications

• High School Diploma or equivalent required; AS/BS preferred.
• Preferred field of study: a science-related discipline.
• 0–3 years of experience; prior manufacturing experience preferred.