About this role
Role Responsibilities:
Utilize PAT analytical instrumentation (e.g., NIR, FBRM Instruments, APC Software) for manufacturing campaigns: including preparation, installation, calibration, and performance checks.Monitor instrumentation output during campaigns using advanced process control software & real-time dashboards & analytics.Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.Responsible for utilizing analytical methodologies, systems, and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product, throughout all phases of development. This may include excipient, packaging, and post packaging supportAnalytical testing would include: compendial testing (e.g., excipients/packaging release testing), disintegration, dissolution, HPLC/UPLC, SFC, generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methodsSet up and analysis of drug substance and drug product stability samples Minimum Qualifications:
Bachelor’s Degree in Analytical Chemistry or related field, with 0 to 2+ years of R&D, engineering, or manufacturing experience.Strong computer, scientific, and organizational skillsExcellent communication (oral and written) and attention to detailAbility to work independently and as part of a team, self-motivation, adaptability, and a positive attitudeAbility to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions & SOPs, and comply with company policiesPreferred QualificationsAt least one year of experience in product development and analytical chemistryExperience with PAT instruments (NIR, FBRM), APC software, chemometrics, and/or data analysis in a GMP environment.Experience with interdisciplinary drug development teams, analytical instrumentation, and method development in a regulated (GMP/GxP) environment.Demonstration of interpersonal skills, teamwork, adaptability, innovation, and initiative Position is full-time, Monday - Friday 8am to 5 pmAbility to work overtime as required.Tasks require repetitive motion and standing for long periods of time.May be required to respond to off-shift operational issues.Candidates currently living within a commutable distance of Groton, CT are encouraged to apply.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.