Manufacturing Associate - cGMP API Production

Eurofins US Network • Groton, CT • 4d ago

Groton, CT, USA

Full-time

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Position Overview

You will be a key member of a multidisciplinary manufacturing team supporting the cGMP production of non-commercial clinical API batches . This role is hands-on and process-driven, contributing directly to API development by executing batch operations, supporting equipment qualification, and ensuring compliance with cGMP and safety standards. Work is performed in a pilot-scale manufacturing environment with close collaboration across Quality, Compliance, and technical teams.

Standard operations involve chemical synthesis of APIs , including solid and liquid handling, distillation, extraction, crystallization, filtration, and drying.

Key Responsibilities

Manufacturing Operations

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.

Documentation & Compliance

Generate, review, and execute cGMP documentation such as:

Batch records

Cleaning records

In-process control sampling documentation

Support equipment commissioning and qualification activities.

Participate in SOP periodic reviews .

Report deviations, observations, or safety concerns that may impact product quality or process safety.

Ensure proper handling, segregation, and disposal of manufacturing waste in compliance with environmental and safety requirements.

Collaboration & Continuous Improvement

Communicate effectively across cross-functional teams including Quality, Compliance, Process Chemists, Analysts, and Supervisors.

Actively participate in shift handovers and operational communications.

Identify and implement continuous improvement opportunities .

Prioritize personal workload and support less-experienced colleagues in task planning and execution.

Complete required training and participate in facility safety inspections.

Qualifications

High School Diploma or GED required

4+ years of relevant manufacturing experience

Demonstrated experience in a cGMP pharmaceutical manufacturing environment

Working knowledge of Production Control Systems

Strong troubleshooting, problem-solving, and critical-thinking skills

Ability to work independently while contributing effectively within a matrix team

Strong organizational skills, attention to detail, and follow-through

Physically capable of:

Standing for extended periods

Lifting =50 lbs

Wearing PPE and working with hazardous materials

Excellent written and verbal communication skills

Proficient in Microsoft Office (Word, Excel)

Preferred Qualifications

Associate degree in a scientific or technical discipline

Strong mechanical aptitude with a hands-on mindset

Experience with DeltaV Production Control System

Experience supporting API manufacturing in a cGMP environment

Hands-on experience with large-scale distillation, filtration, drying, or milling operations

Additional Information

After the initial training period of approximately 3 months which will be Monday- Friday from 8am-5pm team members move to swing shift, which alternates between 1st shift and 2nd shift:1st Shift is Mon-Fri, 6:00 am to 2 pm2nd Shift is Mon - Thurs, 2 pm to 12 pm

May be requested to work on weekends, overtime, and holidays based on business needs.

Candidates currently living within a commutable distance of Groton, CT are encouraged to apply.

Ability to work overtime as required.

Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

LI-EB1

Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

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