QC Analyst I: CGT Analytics & UHPLC Method Development

Artis BioSolutions; Watertown (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

Landmark Bio in Watertown, MA is seeking a QC Analyst I to perform laboratory testing in a fast-paced GMP environment, focusing on UHPLC-based purity/residual analyses and PCR-based CGT testing. You will support method development, qualification, transfer, and troubleshooting while collaborating with cross-functional teams.

The role requires hands-on lab work, knowledge of cGMP requirements, and the ability to manage multiple tasks with excellent documentation practices.

Qualifications

• Hands-on operation of UHPLC instrumentation in a regulated environment.
• Working knowledge of molecular biology/biophysical techniques for DNA/RNA characterization.
• Hands-on experience with PCR platforms and related assays.
• Working knowledge of proteomic or cell-based CGT QC techniques.
• Familiarity with compendial methods is a plus.

Responsibilities

• Execute analytical test methods with cGMP compliance to support CGT manufacturing and release.
• Develop and optimize analytical assays for qualification and transfer to QC.
• Maintain equipment and perform bench tasks with accurate documentation.
• Generate and review GMP protocols, reports, and documentation.

Skills

UHPLC operation

Molecular biology knowledge

PCR platforms experience

Proteomic or cell-based techniques

Familiarity with compendial methods

Education

Bachelor's degree with 2 years experience

Master's degree with 1 year experience

Tools

Aggilent/Waters UHPLC systems

Job description

Landmark Bio in Watertown, MA is seeking a QC Analyst I to perform laboratory testing in a fast-paced GMP environment, focusing on UHPLC-based purity/residual analyses and PCR-based CGT testing. You will support method development, qualification, transfer, and troubleshooting while collaborating with cross-functional teams.

The role requires hands-on lab work, knowledge of cGMP requirements, and the ability to manage multiple tasks with excellent documentation practices.