Work Location: Middlesex County, Massachusetts

Summary:

Seeking a highly motivated analytical research associate to support analytical method development and characterization efforts for innovative delivery platforms and therapeutic modalities. This position involves working closely with a team to drive method development, pre-qualification, and sample analysis for various platforms supporting preclinical programs. The role requires in-office/lab presence five days per week.

Responsibilities:

• Develop, optimize, and pre-qualify analytical methods using chromatographic, capillary gel electrophoresis, plate-based, and biophysical techniques for characterization of LNP, mRNA, and AOC materials.
• Compile, analyze, and present complex analytical data sets to cross-functional teams, providing clear, data-driven recommendations for next steps.
• Troubleshoot instrumentation and method performance issues, and oversee routine equipment maintenance and system performance checks.
• Execute established analytical methods to quantify critical quality attributes for preclinical studies.
• Author and review analytical method protocols, qualification protocols, reports, and standard operating procedures (SOPs).
• Maintain detailed, audit-ready records of experiments and results in electronic notebooks and relevant data archiving systems.
• Contribute to the development of departmental best practices, evaluate new analytical technologies, and support continuous improvement of analytical workflows.
• Collaborate with team members to ensure high-quality analytical support for preclinical programs and delivery platforms.

Qualifications:

• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Analytical Chemistry, Biochemistry, Chemistry, or a related field, with 3–5 years of analytical method development experience in the biopharma industry.
• Hands-on experience developing content- and purity-based methods for large molecules, such as mRNA and antibodies, using chromatographic techniques including RP, AEX, HIC, and SEC.
• Experience maintaining and troubleshooting UPLC/HPLC systems from major vendors, as well as mass spectrometry instruments such as Orbitrap or equivalent.
• Experience characterizing biologics or mRNA/siRNA using high-resolution mass spectrometry platforms.
• Experience with, or working knowledge of, plate-based assays (fluorescence, UV, luminescence) and capillary gel electrophoresis.
• Familiarity with biophysical characterization techniques, such as DLS and SEC-MALS.
• Strong scientific and technical writing skills, with the ability to organize and clearly communicate large data sets to cross-functional teams.
• Commitment to core values including respect, integrity, excellence, and impact.

Published Category: Analytical & Process Development