Translational Research Scientist

2 weeks ago

Gaithersburg, United States Cartesian Therapeutics Full time
Job DescriptionJob Description

Summary

Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases. The Company's lead asset, Descartes-08, is a potential first-in-class mRNA CAR-T in Phase 2b clinical development for patients with generalized myasthenia gravis and Phase 2 development for systematic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. The Company's clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T.

Cartesian Therapeutics is seeking an experienced Translational Research Scientist or Senior Scientist specializing in clinical biospecimen analysis to join our team. This role is integral to advancing clinical and translational research efforts across Cartesians early- to late-stage clinical trials. The successful candidate will bring subject-matter expertise in immunoassay techniques, assay development, and fit-for-purpose regulatory strategies. The individual will play a critical role designing and leading analysis of biospecimens using an array of assays to evaluate analytes and biomarkers relevant to drug development and clinical trials.

The Translational Research Scientist or Senior Scientist will support key responsibilities of the Translational and Clinical Division within Cartesian's R&D Department. This structure leverages the extensive subject matter expertise and experience and scientific excellence of the R&D Department to support Product development through tightly-networked collaboration with Cartesian's Clinical, Manufacturing and QC, and Manufacturing Science and Technology groups.

The ideal candidate will be highly motivated, detail-oriented, and capable of providing high-quality benchwork and technical support in a team setting that values communication and collaboration. The candidate should be comfortable working in a multidisciplinary team, maintaining biobanks, managing and following SOPs, and keeping accurate and timely experimental records.


Principal Duties/Responsibilities:

  • Work with division leadership to align on goals for specific trials/assets and collaborate to develop analysis plans and timelines.
  • Coordinate and analyze samples using immunoassays (ELISA, Luminex, Meso Scale, etc) and cell assays (flow cytometry), maintenance of biobanks and inventories, developing assays, and reporting to cross-functional teams.
  • Perform analysis, quality control, and data reporting on clinical samples using immunoassay techniques including ELISAs, multiplex analysis and flow cytometry
  • Take ownership of specific mechanism of action studies on clinical samples to support R&D and development needs
  • Prepare blood-derived samples (serum, plasma) from clinical samples
  • Maintain and manage sample biobanks and inventories
  • Develop and optimize new assays, support experimental design, assay evaluation and reporting
  • Prepare and implement SOPs to ensure accuracy and reproducibility of assay results
  • Serve as subject matter expert for technical performance and assay performance of biospecimen analysis
  • Document experimental data records and maintain protocols following good documentation practices
  • Contribute to general laboratory maintenance and organization

Qualifications:

  • Education
    • Masters or PhD degree in biology or life sciences, or a related field
    • At least 5 years post-Masters's experience in immunoassay analysis on biospecimens
    • At least 2 years of translational research or clinical immunology experience in an industry setting post-PhD/Masters
  • Technical Expertise
    • In depth hands-on experience and technical knowledge of immunoassay and other analytical techniques in the context of clinical sample analysis
    • Experience with aseptic and cell culture techniques
    • High level of technical expertise and attention to detail in laboratory work and record keeping
    • Experience with standard life science laboratory equipment
  • Additional Skills
    • Excellent time management, organizational and documentation skills
    • A good understanding of statistical analysis and communication of translational research data
    • Experience with immunoassays in a regulated environment with Good Clinical Laboratory Practice or comparable is highly desirable
    • Background in assay development related to immunoassays and flow cytometry is desirable
    • Experience and aptitude for development and implementation of translational or biomarker strategies, preparation of scientific publications, presentations, and regulatory documents is a plus
    • Local candidates are highly preferred

Job Type:

  • Full-time, M-F with occasional weekend obligations

Cartesian is an Equal Opportunity Employer and is committed to fostering an environment in which all employees are treated fairly without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, ancestry, disability, marital status, genetic information, military status, or any other characteristic protected under applicable law.



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