About this role
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 chargingAtmospheric and vacuum distillationLiquid‑liquid extractions and phase separationsCrystallization, filtration, milling, and dryingPerform 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 recordsCleaning recordsIn‑process control sampling documentationSupport 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. High School Diploma or GED required4+ years of relevant manufacturing experienceDemonstrated experience in a cGMP pharmaceutical manufacturing environmentWorking knowledge of Production Control SystemsStrong troubleshooting, problem‑solving, and critical‑thinking skillsAbility to work independently while contributing effectively within a matrix teamStrong organizational skills, attention to detail, and follow‑throughPhysically capable of:Standing for extended periodsLifting ≥50 lbsWearing PPE and working with hazardous materialsExcellent written and verbal communication skillsProficient in Microsoft Office (Word, Excel)Preferred Qualifications
Associate degree in a scientific or technical disciplineStrong mechanical aptitude with a hands‑on mindsetExperience with DeltaV Production Control SystemExperience supporting API manufacturing in a cGMP environmentHands‑on experience with large‑scale distillation, filtration, drying, or milling operations 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 pm
2nd 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 optionsLife and disability insurance401(k) with company matchPaid vacation and holidays#LI-EB1Authorization to work in the United States indefinitely without restriction or sponsorshipEurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.