• Responsible for utilizing analytical methodologies, systems , and processes to support drug substance and drug product development throughout all phases.
• Prepare, set up, and analyze drug substances and/or drug product samples using a variety of analytical techniques including chromatography (e.g., HPLC, UPLC, LCMS GC, GCMS, SFC), spectroscopy (e.g., UV-Vis, NMR), dissolution, and other relevant methodologies (e.g., KF, pH, ROI).
• Support development and optimization of analytical methods, including assay, purity, dissolution, and/or impurity characterization approaches as appropriate.
• Execute method qualification, validation, and transfer activities to support development and commercialization programs.
• Conduct degradation, stability, and investigational studies to support the evaluation of product performance and risk.
• Assess stability, dissolution, and/or impurity trends to support product and process development decisions.
• Support analytical method and technology transfer activities across laboratories and development sites.
• Operate, maintain, calibrate, and troubleshoot analytical instrumentation under guidance.
• Read and understand analytical methods, SOPs, compendial procedures, and GMP requirements while maintaining accurate documentation and data integrity within electronic laboratory systems.
• Demonstrate strong ownership of quality, safety, productivity, organization, and client service expectations.
• Perform other duties as assigned
• Bachelor’s degree in chemistry, biochemistry, or other related degree concentration with 2-4 years of experience, Masters or Engineers with 0-2 years of related experience.
• Basic laboratory skills and following written procedures, protocols, and work instructions accurately
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivated, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Experience in GMP laboratory, analytical chemistry
• Experience with eLN and data trending
• Position is full-time, working Monday-Friday 8:00 a.m.-5:00p.m overtime as needed
• 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 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.