Our RESETTM clinical trials with CABA-201 (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, and myasthenia gravis are now recruiting.

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Associate Director, Technical Development (Lentiviral Vectors)

About the Position

Cabaletta Bio is seeking a talented and experienced Associate Director, Technical Development with process and analytical development and / or manufacturing experience in lentiviral vectors to oversee technical development activities at our CDMO. Reporting to the Vice President of Technical Development, the successful candidate will bring in-depth knowledge and hands-on experience in the development, optimization, and characterization of lentiviral vectors, with a specific emphasis on supporting BLA filings. This position requires a strong process and analytical background and knowledge of regulatory requirements in cell and gene therapy.

Responsibilities Include

  • Lead technical development work at CDMO for lentiviral vector. Participate in technical discussions to drive experimental design and data review. Ensure CDMO performs at a high level.
  • As a technical expert on LVV manufacturing process, collaborate with External Manufacturing and Quality representatives to oversee the LVV manufacturing campaigns at CDMO.
  • Collaborate with analytical development team to design, develop, and optimize analytical methods for lentiviral vector characterization.
  • Collaborate with process development team to ensure LVV process associated impurity levels are appropriate for drug product processing, ensuring safety of cell product and compliance with regulatory standards and guidelines.
  • Stay up-to-date on the latest advancements in process and analytical techniques and contribute to the continuous improvement of related methodologies.
  • Lead and contribute to the preparation of agency submissions related to lentiviral vectors, ensuring compliance with regulatory requirements.
  • Act as a subject matter expert in interactions with regulatory agencies regarding lentiviral vector process and characterization.
  • Generate and communicate research findings through presentations, scientific publications, and contributions to regulatory documents.
  • Stay abreast of emerging technologies, methodologies, and scientific literature in the fields of lentiviral vector and cell therapy and apply this knowledge to advance research objectives.
  • Provide technical guidance, mentorship, and training to junior scientists and research associates within the team.
  • As needed, act as a technical expert on projects relating to future manufacturing of cell therapy products.

Required Qualifications

  • Ph.D. in molecular biology, virology, cell biology, or immunology and 6+ years of relevant work experience
  • Proven expertise in CGT process and/or analytical development, validation, and troubleshooting
  • Experience working in a regulated environment, with a strong understanding of cGMP regulations and guidelines applicable to biologics manufacturing and BLA filing.
  • Excellent written and verbal communication skills, with the ability to effectively collaborate with multidisciplinary teams and communicate technical information to diverse audiences.
  • Working knowledge of regulatory requirements and quality standards relevant to cell therapy research and development.
  • Experience working with and managing technical aspects of CDMO collaborations.
  • Strong team orientation and passion for continuous self-development. 
  • Experience in the biotech industry or in a startup industrial setting is preferred. 


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How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.