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

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Senior Scientist, Lentiviral Vectors

Philadelphia, PA

About the Position

We are seeking a talented and experienced Senior Scientist with analytics and / or manufacturing experience in lentiviral vectors, especially with Biologics License Application (BLA) filing.  Reporting to Principal Scientist, 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, to join our innovative Analytical Development team. This position requires a strong background in analytical techniques, method development, and regulatory compliance.

Join us in our mission to advance the field of cell therapy to cure autoimmune diseases through innovative approaches. If you are passionate about leveraging knowledge of analytical testing and manufacturing process for lentiviral vector used in ex vivo cell therapies, to enhance the efficacy and safety of CAART and CARTA cell therapies, we invite you to apply and contribute your expertise to our dynamic team.

Responsibilities Include

  • Design, develop, and optimize analytical methods for lentiviral vector characterization and lentiviral vector /process associated impurities in cell product, ensuring safety of cell product and compliance with regulatory standards and guidelines.
  • Stay the latest advancements in analytical techniques and contribute to the continuous improvement of analytical methodologies.
  • Lead technical aspects of viral vector development, product and process characterization and manufacturing related issues at external CDMO
  • Lead and contribute to the preparation of BLA submissions related to lentiviral vectors, ensuring compliance with regulatory requirements.
  • Collaborate with cross-functional teams to compile and analyze analytical data for regulatory submissions.
  • Act as a subject matter expert in interactions with regulatory agencies regarding analytical aspects of lentiviral vector characterization.
  • Conduct routine analytical testing of lentiviral vectors to support process development, manufacturing, and quality control activities.
  • Troubleshoot and resolve any analytical challenges that may arise during routine testing.
  • 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.

Required Qualifications

  • Master’s degree in molecular biology, virology, cell biology, or immunology and 3-5 years of relevant experience or Ph.D. or equivalent degree in molecular biology, virology, cell biology, immunology, or a related discipline with 2-4 years of experience.
  • Proven expertise in analytical method development, validation, and troubleshooting, with a focus on lentiviral vector analytics.
  • Hands-on experience with a wide range of analytical techniques commonly used in biopharmaceutical development, such as qPCR, ddPCR, ELISA, HPLC, and flow cytometry.
  • 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.
  • Prior experience in project leadership, including experimental design, project planning, and supervision of research activities.
  • Knowledge of regulatory requirements and quality standards relevant to cell therapy research and development is advantageous.


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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.