QC Analyst 1

Landmark Bio • Watertown, MA

1d • Onsite

About The Position

The Quality Control - Analytics department supports a growing portfolio of cell and gene therapy (CGT) products, including CAR-T, iPSC, AAV, LVV and synthetic DNA products. We are immediately recruiting for a highly motivated QC Analyst I to perform laboratory testing with distinct technical but complementary focus within a fast-paced GMP environment. You will contribute to the development, qualification and execution of analytical methods supporting GMP release and characterization testing. Additionally, you will work cross-functionally with Analytical / Process Development, Manufacturing, and Quality Assurance to ensure methods meet regulatory and compendial expectations while supporting patient safety. This is an outstanding opportunity for a candidate to work under the guidance of a supervisor and mentor, manage time effectively, complete assigned analytical tasks in a cross-functional collaborative environment supporting development and cGMP manufacturing of cell and gene therapies. This role focuses on the development and optimization of UHPLC-based biophysical analytical methods and/or PCR-based, and related molecular methods supporting CGT safety, identity, purity, strength and quality testing, including residual impurity and compendial applications such as Mycoplasma detection.

Requirements

• Hands-on operation of UHPLC instrumentation (e.g., Agilent, Water’s platform) in a regulated or research setting.
• Working knowledge of molecular biology and/or biophysical characterization techniques applicable to DNA, RNA, or plasmid characterization.
• Hands-on experience with PCR platforms and related molecular assays.
• Working knowledge of proteomic or cell-based techniques used in CGT QC.
• Demonstrate working knowledge of cGMP requirements.
• Ability to manage and prioritize tasks and projects, with the guidance of management.
• Strong verbal and written communication skills.
• Strong leadership skills, with an excitement to both roll up your sleeves and be a thoughtful partner.
• Detail-oriented with strong problem solving and troubleshooting skills.
• Applicants must possess valid, unrestricted work authorization and be available to commence work immediately upon offer.

Nice To Haves

• Familiarity with compendial methods is a plus.

Responsibilities

• Complete required read/understand courses, bench-work training and quality-controlled cGMP documentation requirements.
• Execute assigned analytical test methods, with cGMP compliance, to support cell therapy manufacturing, vector manufacturing, and fill finish.
• Support analytical assay development ensuring they are robust enough for qualification, transition to quality control and successful implementation.
• Perform general laboratory tasks, including maintenance and troubleshooting of equipment.
• Maintain accurate and reliable records, electronic lab notebook entries, and all other pertinent documentation.
• Comply with all environmental health and safety standards.
• Develop, optimize, and troubleshoot UHPLC-based methods (e.g., reverse phase, ion-pair, size exclusion etc.) for purity analysis of small molecules, DNA, RNA, and related CGT residuals.
• Apply molecular biology and biophysical characterization techniques to support method development.
• Support technical transfer and method qualification activities.
• Generate and review technical protocols, reports and GMP documentation.
• Troubleshoot chromatographic performance issues (e.g., peak shouldering, tailing, resolution) and propose corrective strategies.
• Develop and optimize PCR methods applicable to CGT drug substance/drug product testing.
• Support compendial and non-compendial molecular testing.
• Support method transfer, qualification and troubleshooting activities.
• Generate and review technical protocols, reports and GMP-compliant documentation.
• Contribute to assay development activities using cell-based and/or proteomics-based approaches, e.g., cell culture-based cytotoxicity assays, flow cytometry, ELISA/plate-reader-based assays as applicable to CGT QC.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level