Join Our Crew

Supply Chain Specialist / Supply Chain Manager

Philadelphia, PA

About Cabaletta Bio

Cabaletta Bio (NASDAQ: CABA) is focused on the discovery and development of T cell therapies for B cell-mediated autoimmune diseases. Our proprietary technology utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to precisely bind and destroy only specific autoantibody-expressing B cells while sparing normal antibody-expressing B cells, which are essential for human health. Cabaletta’s Approach for selective B cell Ablation platform, called our CABA™ platform, has applicability across more than two dozen B cell-mediated autoimmune diseases that we have identified, reviewed and prioritized. CAAR T technology 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 CAAR T technology to treat B cell-mediated autoimmune diseases.

The Company’s lead product candidate, DSG3-CAART, received IND clearance from the FDA in September 2019, and initial safety data in clinical trials has been reported. DSG3-CAART is designed to be a potential treatment for patients with mucosal pemphigus vulgaris (mPV), which is a rare autoimmune blistering disorder that causes painful blisters and sores on mucous membranes leading to severe and sometimes debilitating and life-altering effects. Cabaletta Bio is also pursuing additional pipeline candidates for other B cell mediated disorders including MuSK Myasthenia Gravis (MG) with an IND planned for 2H 2021, mucocutaneous PV, PLA2R positive membranous nephropathy (PMN), and Factor VIII inhibitors.

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 on an interim basis to the Director, Manufacturing Science & Technology, and longer term into the Manufacturing organization, (when established), the Supply Chain Specialist / Supply Chain Manager will be responsible for establishing and leading the cold chain logistics processes in manufacturing operations at Cabaletta Bio as well as developing the function as the company increases the number of clinical sites and clinical trials, expands its pipeline, and evolves from early phase to commercial scale logistics.

Specifically, the Specialist will execute all supply chain and drug manufacturing logistics supporting clinical trial execution, such as project management, production planning for clinical needs, evaluation of vendors’ logistics capabilities and services, and identification and implementation of innovative solutions. The Specialist will be responsible for building effective partnerships with internal and external stakeholders, including Clinical Operations, Quality Assurance, Manufacturing, Contract Manufacturing Organizations (CMOs), and Supply Chain Logistics/Distribution Vendors. The Specialist will also manage shipping partners on all needed supply chain reporting.

Responsibilities Include

  • Maintain oversight of vein-to-vein Clinical Supply Management for Cabaletta’s engineered T cell products.
  • Manage all aspects of patient leukapheresis material and Investigational Product (IP) delivery to meet patient dosing timeframes.
  • Work with the clinical operations, manufacturing, analytic and quality teams to confirm the suitability of manufacturing timeframes, labelling and dosing instructions for clinical sites, product QA release timeframes, product distribution logistics, site infusion training and final product disposition.
  • Coordinate with internal and external stakeholders for managing end-to-end logistics processes for patient material/product shipping and receiving and mock shipment, including:
    • Coordinating with clinical sites, manufacturing and couriers to schedule and track shipments.
    • Managing and monitoring couriers, including proactive communication to all stakeholders regarding shipping delays and changes and identification and implementation of effective problem solving.
    • Providing accurate and timely updates and information to internal and external stakeholders regarding shipping plans, contingencies, and status.
    • Proactively anticipating cold chain technical problems and obstacles, implementing effective risk management plans, and appropriately adjusting logistics and training plans to meet patient needs.
    • Performing discrepancy investigations working within established Quality Department infrastructure.
    • Supporting clinical site capability assessments and training, including participating in clinical site evaluation and initiation visits, leading mock shipments to and from clinical and manufacturing sites, and assessing the need for and performing additional site training.
    • Providing technical support to sites regarding apheresis cryopreservation, packing supplies and procedures, and accurate completion of shipment documentation.
  • Evaluate opportunities to expand the range of contract logistics capabilities and services, implement continuous improvements, and develop trusted partnerships with key internal and external stakeholders.
  • Support procurement, receipt and tracking of laboratory components and biological materials.
  • Support the shipping, receiving, and inventory management of investigational material and biological samples for pre-clinical and clinical/translational development projects including clinical subject biological samples.
  • Oversight of internally and externally stored clinical investigational and subject biological samples to ensure traceability and compliance with informed consent. Performs periodic reconciliation of received and stored samples against clinical trial database.  
  • Coordinate with external plasmid and vector CMOs, tracking the timeline of production, release, shipping, and risk-mitigated storage, to ensure the supply for clinical trials.
  • Represent Manufacturing, Science & Technology group on internal teams, as appropriate and undertake specific projects within the group on as-needed basis.
  • Maintain all individual training requirements in a compliant state.

Depending upon skills and bandwidth, the Specialist may also engage in the following activities in Manufacturing Technology:

  • Support process development work as needed, such as sampling, cell freezing, cell maintenance and cell processing.
  • Support external cell CMOs’ development activities, including tracking materials and equipment purchasing timelines for tech transfer and tracking supply for manufacturing production.
  • Maintain laboratory product material and sample inventory, support the planning of materials needs and coordinate purchasing with lab manager.

Required Qualifications

  • Bachelor's degree in supply chain management or relevant discipline.
  • Minimum of 5 years operations planning experience, preferably within pharmaceutical or biotech industry, with at least two of those years planning virtual supply chains for clinical and/or pharmaceutical materials.
  • Experience with cell and gene therapy (early stage, late stage or commercial) logistics and supply chain, including cold supply chain & chain of custody is required.
  • Strong relationship building, interpersonal and communication skills required. Collaborates effectively internally and externally.
  • Highly motivated, proactive and organized. Able to work effectively, efficiently and independently. Strong problem-solving skills.
  • Advanced knowledge of Microsoft Excel/Access and proficiency in operational planning.
  • Ability to coordinate and prioritize parallel tasks across multiple projects.
  • Experience with project management is preferred.
  • Experience with external manufacturing organizations is preferred.
  • Flexibility to work in a fast-paced environment in interacting with cross-functional teams, CMOs and vendors.

How to Apply

Please email careers@cabalettabio.com directly to submit an application.

Please include your CV along with the title of the position you are applying for.

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.