Position: Associate Director, Technical Development (Lentiviral Vectors)

 

Philadelphia, PA 

 

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter). 

 

Uniquely Differentiated. Rapid. Elegant. 

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.  

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work® 

 

Position Description:

We are 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.

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.

 

 

Job Responsibilities:

  • 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.

 

Requirements:

  • 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. 

 

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression. 

 

For more information, please visit  https://www.cabalettabio.com/join-our-crew 

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

 

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. 

 

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation. 

 

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm. 

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