Director of GMP Quality
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
Reporting to the VP of Compliance, we are seeking an experienced and motivated Director of Quality to provide quality oversight of production activities for Cabaletta’s CAAR T GMP manufacturing. This includes supporting and approving manufacturing investigations and ownership over GMP quality department projects. This position will lead quality activities at Cabaletta’s manufacturing partners and will require up to 20% – 30% domestic travel.
Responsibilities Include to
- Serve as the Quality support of cell therapy manufacturing at CMOs and direct point of contact.
- Provide management of compliance activities for site Quality Operations in accordance with Cabaletta SOPs and cGMPs.
- Collaborate with CMO site personnel to provide guidance and determine resolution for manufacturing issues.
- Ensure accurate and timely review and maintenance of manufacturing investigations, CAPAs, change controls, and complaints.
- Provide operational leadership and expertise in the development, implementation, and training of cGMP compliant quality systems.
- Review and approve manufacturing procedures.
- Support regulatory and conduct audits by ensuring inspection readiness within facility.
- Perform analysis on quality data and identify trends.
- Bachelor’s degree in sciences or related field with 5+ years of relevant biopharmaceutical industry experience in Quality Assurance leadership.
- Strong knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based therapies.
- Experience managing CRO/CMO relationships and providing quality oversight.
- Internal and external site GMP audit, as well as FDA regulatory interaction.
- Highly organized and a proven track record of successful technical knowledge within GMP quality regulations.
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 firstname.lastname@example.org 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.