Manufacturing Associate - cGMP API Production

1w1 week ago

Eurofins

Groton, US · Full-time · $55,000 – $75,000

About this role

You will be a key member of a multidisciplinary manufacturing team supporting cGMP production of non-commercial clinical API batches. This hands-on, process-driven role contributes directly to API development by executing batch operations and supporting equipment qualification. Compliance with cGMP and safety standards is essential in this pilot-scale environment.

Standard operations involve chemical synthesis of APIs, including solid and liquid handling, distillation, extraction, crystallization, filtration, and drying. Execute Process Operating Instructions and batch records in a regulated cGMP environment while preparing, operating, monitoring, sampling, and cleaning complex equipment per SOPs.

Perform routine manual material handling, including lifting loads ≥50 lbs using proper safety techniques. Identify, troubleshoot, and resolve equipment and process issues with close collaboration across Quality, Compliance, and technical teams.

Generate, review, and execute cGMP documentation such as batch records, cleaning records, and in-process control sampling. Support equipment commissioning, qualification activities, SOP periodic reviews, and report deviations or safety concerns to ensure product quality and process safety.

Requirements

Familiarity with cGMP (GxP) manufacturing environments
Hands-on experience with chemical synthesis operations including distillation, extraction, crystallization, filtration, and drying
Ability to safely handle solids, liquids, and perform manual material handling of loads ≥50 lbs
Proficiency in following SOPs for equipment operation, cleaning, and sampling
Attention to detail for accurate cGMP documentation and batch record execution
Skills in troubleshooting equipment and process deviations
Knowledge of safety protocols for chemical processing and waste disposal

Responsibilities

Execute Process Operating Instructions and batch records in a regulated cGMP (GxP) environment
Prepare, operate, monitor, sample, and clean complex pharmaceutical manufacturing equipment according to SOPs
Perform hands-on chemical processing activities, including solid and liquid charging, atmospheric and vacuum distillation, liquid-liquid extractions and phase separations, crystallization, filtration, milling, and drying
Perform routine manual material handling, including lifting and moving loads ≥50 lbs using proper safety techniques
Identify, troubleshoot, and resolve equipment and process issues
Generate, review, and execute cGMP documentation such as batch records, cleaning records, and in-process control sampling documentation
Support equipment commissioning and qualification activities
Participate in SOP periodic reviews and report deviations, observations, or safety concerns