QC Chromatography Associate – HPLC Method Dev & GMP

Terrestrial; Woburn (MA); On-site; USD 60,000 - 75,000; Full time

Job summary

Terrestrial Bio, Inc. is seeking a detail-oriented Research Associate to join our QC team in the Woburn/Allston area. You will perform routine in-process, release, and stability testing using HPLC/UPLC methods, develop and troubleshoot assays, and maintain rigorous documentation in a cGMP/GLP setting.

The role emphasizes collaboration across QC, Analytical Development, and Regulatory teams, with onsite work 4–5 days per week at our MA facilities.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field with 1–3 years of experience; or a master’s degree with relevant laboratory experience.
• Hands-on experience operating HPLC/UPLC systems; Agilent systems and OpenLab CDS experience strongly preferred.
• Practical experience with chromatographic techniques including reverse-phase, SEC, and IEX.
• Experience supporting QC release or stability testing in a GMP-aligned/GLP environment.
• Strong attention to detail and ability to follow SOPs precisely.

Responsibilities

• Perform routine QC in-process, release, and stability testing using HPLC/UPLC methods including reverse-phase, SEC, and IEX
• Perform HPLC/UPLC method development and troubleshooting in collaboration with senior scientists to support the QC workflow
• Prepare samples, operate Agilent systems, verify system suitability, and ensure analyses meet method and specification requirements
• Execute complementary analytical assays such as UV-Vis, pH, surface tension, and mechanical tests
• Maintain complete, accurate documentation in compliance with cGMP, ALCOA+, and data integrity requirements
• Conduct routine instrument care (solvent flushes, column care, daily checks)
• Process and review chromatographic data in Agilent OpenLab CDS
• Support method qualification, validation, and transfer activities by executing protocols and recording observations
• Maintain calibration, maintenance, and service records for analytical instrumentation
• Write and maintain key technical documentation including SOPs, analytical protocols, technical reports, and audit-ready records; contribute to regulatory submissions
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success

Skills

HPLC/UPLC operation

Agilent systems experience

OpenLab CDS experience

Education

Bachelor’s degree in Chemistry/Biochemistry/Chemical Engineering

Master’s degree with relevant laboratory experience

Tools

Agilent OpenLab CDS

Agilent instruments

Job description

Terrestrial Bio, Inc. is seeking a detail-oriented Research Associate to join our QC team in the Woburn/Allston area. You will perform routine in-process, release, and stability testing using HPLC/UPLC methods, develop and troubleshoot assays, and maintain rigorous documentation in a cGMP/GLP setting.

The role emphasizes collaboration across QC, Analytical Development, and Regulatory teams, with onsite work 4–5 days per week at our MA facilities.