QC Analyst 1

Landmarkbio; Watertown (MA); On-site; USD 60,000 - 75,000; Full time

Job summary

Landmark Bio is seeking a QC Analyst I for the Quality Control – Analytics team to perform UHPLC and PCR based testing in a fast-paced CGT manufacturing environment.

You will develop and optimize UHPLC‑based purity and residual methods, support method transfer and qualification, and maintain rigorous GMP‑compliant documentation to ensure product safety and quality throughout development and manufacturing.

Qualifications

• Hands-on UHPLC in regulated setting.
• Molecular biology/biophysical knowledge applicable to CGT QC.
• Hands-on experience with PCR platforms.
• Familiarity with CGT QC testing.
• cGMP familiarity required.

Responsibilities

• Execute analytical test methods under cGMP.
• Develop and optimize UHPLC and PCR methods.
• Support method transfer and qualification activities.
• Maintain lab records and GMP documentation.
• Ensure environmental health and safety standards.

Skills

UHPLC hands-on

Molecular biology

PCR platforms

Proteomics

cGMP knowledge

Documentation

Education

Bachelor's degree

Master's degree

Tools

UHPLC instruments (Agilent/Waters)

Job description

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 a distinct technical but complementary focus within a fast‑paced GMP environment. 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) 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 such as peak shoulder, tailing or 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, Waters 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.

Landmark Bio is an Equal Opportunity, Affluent Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.