Associate Director/Director, Supplier Management

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases. The CARTA strategy, or Chimeric Antigen Receptor T cells for Autoimmunity, is designed to potentially reset the immune system by causing transient B cell depletion with early academic clinical data suggesting the potential of this strategy to transform treatment in patients with SLE and the possibility of cures in rheumatoid arthritis, myositis, and systemic sclerosis, among others. Our lead product candidate using the CARTA strategy is CABA-201, 4-1BB-containing CD19-CAR T designed specifically to treat patients with autoimmune diseases with high unmet need, including systemic lupus erythematosus (SLE), myositis, systemic sclerosis, and generalized myasthenia gravis, and which uses a CD-19 binder that has an encouraging clinical tolerability profile. In addition to our CARTA candidate, CABA-201, we have a clinical-stage pipeline of Chimeric AutoAntibody Receptor T (CAART) cells targeted to the cells responsible for autoantibody-mediated autoimmune diseases.  Cabaletta Bio's headquarters 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

About the Position

The Associate Director/Director, Supplier Management will provide operational oversight of Contract Manufacturing Organizations (CMOs) and key suppliers within our growing network. This person will assist in the overall design and execution of our supplier governance structure as well as be accountable for managing the supply from our CMOs on a day-to-day basis.  The Associate Director/Director, Supplier Management will work closely with Process and Analytical Development, Clinical Operations, Quality, and other Supply Chain functions to assure supply of product to our patients.

Responsibilities:

• Assist in the design, and lead the execution, of the external supplier governance structure for the Supply organization, including a segmentation strategy to ensure right-sized management of all suppliers across the supply chain.
• Establish business processes and cross-functional relationships with internal and external partners, including senior leaders at the CMO.
• Lead matrixed cross-functional teams internally and with CMOs to support production across the end-to-end supply chain.
• Ensure that all contractual obligations with our CMOs are met to Cabaletta Bio Quality standards, including on-time manufacturing, QC testing, QMS record closure and batch disposition.
• Create and maintain internal cross-functional data tracking tools to monitor E2E batch performance via newly established KPIs and metrics.
• Act as internal and external escalation point for CMO-related discussions
• Coordinate business review series at CMOs to review metrics/KPIs/overall health of business
• Provide front-line support for process or equipment related issues at the CMO and ensure cross-functional engagement internally.
• Lead or drive the resolution of major and critical deviation investigations.
• Partner with Process Development and Quality to tech transfer and qualify/ validate manufacturing processes and QC methods.
• Assist in contract negotiation and onboarding of new CMOs

Qualifications:

• Bachelor's degree in engineering, life sciences or related field.
• 7-10 years' relevant experience in life sciences manufacturing, process development, or similar and experience in managing external partners.
• Experience in biologics or cell/gene therapy preferred.
• In-depth knowledge of GMP regulations and a commitment to operational excellence.
• Strong project management, organizational, collaboration, and conflict resolution skills and experience.
• Proven strong and visible leadership with the ability and influence other functions within the organization
• Experience designing and implementing business processes to meet departmental and corporate needs
• Ability to work multifunctionally across a customer-centric organization
• Strong team orientation and passion for continuous self-development.

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.