Manager/Senior Manager, Vector Process Development

Philadelphia, PA

Cabaletta Bio is focused on the discovery and development of T cell therapies for B cell-mediated autoimmune diseases. Cabaletta’s therapeutic platform produces highly selective autologous Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to precisely bind and destroy only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The platform is based on the revolutionary Chimeric Antigen Receptor (CAR) T cell technology developed at the University of Pennsylvania that resulted in one of the first commercially-available CAR T cell products for the treatment of B cell malignancies. Cabaletta has an exclusive global licensing agreement and multiple sponsored research agreements with the University of Pennsylvania to develop the CAAR T technology to treat B cell-mediated autoimmune diseases. The Company’s lead therapeutic program is a potential treatment for a prototypical B cell-mediated autoimmune disease, mucosal pemphigus vulgaris (mPV), which is a rare skin disorder that causes painful blisters and sores on mucous membranes leading to severe and sometimes debilitating and life-altering effects.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing a new type of therapy, where patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that success in the Cabaletta mission lies in the hands of individuals across every aspect of the company. To nurture this, we make an active commitment to the well-being and continuous growth of each person who joins our team.  In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew

About the Position

This position reports into the Director of Gene Transfer Technologies and works closely with the VP Process R&D.  The role will lead the scientific and process development efforts around plasmid and lentiviral vector manufacture and will contribute to the evaluation and process development of novel gene transfer technologies.  The position may lead a small team and will be supported by CMC project management.

Responsibilities include to:

  • Pilot both upstream and downstream methods for viral vector production in the process development laboratory.
  • Working with processes provided by external production partners, evaluate and optimize upstream process parameters.
  • Evaluate and as required, develop scalable purification processes for viral vector production.
  • Participate in technology transfer of optimized processes to production partners, and provide technical oversight for GMP production.
  • Evaluate and optimize analytical methods for product release and establish improved methods for drug substance characterization and comparison across production partners.
  • Evaluate novel and emerging technologies for upstream and downstream processes to improve the titer, specific activity, and purity of the vector product.
  • Apply QbD principals to process characterization, establish process parameters, and contribute to CMC sections of regulatory filings.
  • Work with Quality and MS&T for process improvement initiatives to streamline manufacturing or improve process robustness.
  • Responsible for the oversight of external GMP plasmid production and characterization for use in vector production (with support from internal Compliance team).
  • Responsible for the oversight of external GMP protein and RNA production for alternate gene transfer technologies, as required (with support from internal Compliance team).
  • Contribute to cell process development as needed.

Required Qualifications

  • Ph.D. or equivalent experience, in Biological Sciences or related fields with 4 + years’ experience working within upstream and downstream process development activities with enveloped viral vectors or vaccines.
  • Direct pharmaceutical or biotech experience developing mammalian cell culture and vector production processes for manufacture of viral gene therapy vectors or viruses, as well as various molecular biology techniques.
  • Familiarity with cell banking procedures.
  • Knowledgeable in various techniques for transient transfection, including GMP compliant and scale-able processes.
  • Experienced in GMP plasmid production and plasmid technologies.
  • Purification operations utilizing tangential flow filtration, ion exchange and size exclusion chromatography, and sterile and clarification filtration techniques.
  • Good working knowledge of GMP and ICH regulations.
  • Highly organized and efficient, with a curiosity to be part of cutting-edge science.

Preferred Qualifications

  • Experience working with gene editing and/or transposon systems.
  • Expert in transfection technology.
  • Previous experience with team management and the training of more junior level staff.

Our name – Cabaletta – is derived from the operatic term for the second part of an aria that is designed to highlight the technical expertise of the lead singer. While our company is not the first to develop chimeric T cells as therapies, we are the first to develop them in a way that leverages T cells to specifically eliminate only B cells that cause disease, while sparing healthy B cells. Utilizing the backbone of this core technology, we expect to advance our portfolio with a rapid and repetitive rhythm, similar to the rhythm that is typical of a cabaletta.

For more information, please visit https://www.cabalettabio.com/ or email careers@cabalettabio.com directly to submit an application. Please include your CV along with the title of the position you are applying for.

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.