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Watertown, Massachusetts, United States
Onsite
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.
Scope of 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.
This is a hands-on lab-based position requiring flexibility based on cell & gene therapy drug product manufacturing schedule.
UHPLC-Based Methods (Purity and Residual Analysis)
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.
PCR-Based Methods (qPCR / dPCR/ ddPCR)
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
Proteomic and/or Cell-based Methods
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.
Required Experiences
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.
Familiarity with compendial methods is a plus.
Minimum Qualification
QC Analyst I: Bachelors with minimum of 2 years or Masters with minimum of 1 year of relevant work experience, preferably in a cGMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy.
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.
To Apply
Please submit your resume/CV along with a brief cover letter describing your relevant experience for one or more applicable areas indicated above. Your cover letter should specifically address:
Your hands-on experience with relevant technique
Any additional relevant experience
Your familiarity with GMP and regulatory framework applicable to CGT analytical testing.
Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.