QC Analyst 1

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  with in a fast-paced GMP environment .  You will  contribute to the development, qualification and execution of analytical methods supporting GMP release and characterization testing.  Additionally, y ou 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 mo lecular 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 a nalytical assay  development  ensuring they are robust enough for qualification ,  transition to  quality control  and successful implem e ntation .    

• Perform general laboratory tasks, including maintenance and t roubleshooting  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.