Analytical Chemist

Eurofins USA PSS Insourcing Solutions•Groton, CT

3d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in chemistry, biochemistry, or other related degree concentration, or equivalent directly-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
Authorization to work in the United States indefinitely without restriction or sponsorship

Responsibilities

Utilize analytical methodologies, systems, and processes to support drug substance and drug product development.
Prepare, set up, and analyze drug substances and/or drug product samples using various analytical techniques.
Support development and optimization of analytical methods.
Execute method qualification, validation, and transfer activities.
Conduct degradation, stability, and investigational studies.
Assess stability, dissolution, and/or impurity trends.
Support analytical method and technology transfer activities across laboratories and development sites.
Operate, maintain, calibrate, and troubleshoot analytical instrumentation.
Read and understand analytical methods, SOPs, compendial procedures, and GMP requirements.
Maintain 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.