Senior Manager/Associate Director, External Supply Management

Remote OR 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®

This role can be fully remote or hybrid if within commuting distance of our offices in Center City, Philadelphia, PA.

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

Responsibilities:

• Assist in the design and execution of the external supplier governance structure for the Supply organization

• Manage processes and interactions with key vendors for drug substance and drug product manufacturing (i.e. plasmid, vector, and cell manufacturing) 
  
  
  
  • Activities include production management, vendor oversight and relations, issue resolution, communication and collaboration with key stakeholders and partner lines to ensure the required material is released on schedule and meets all necessary requirements
  
  
  
  

• Lead cross-functional teams internally and with CDMOs to support production across the end-to-end supply chain


• Manage and participate in cross-functional teams of internal and external Subject Matter Experts to conduct thorough investigations related to issues that occur during any operations at external partners.


• Ensure appropriate CAPAs are put in place and enforced to mitigate future risk


• Ensure accurate and timely external supply chain information is available for key stakeholders and management processes


• Design and implement relevant tracking tools to aid management of supply chain activities


• Maintain tracking of applicable Key Performance Indicators (KPIs) to measure and manage the performance of the external supply chain


• Ensure that all contractual obligations with our CDMOs are met to Cabaletta Bio Quality standards, including on-time manufacturing, QC testing, QMS record closure and batch disposition


• Coordinate business review series at CDMOs to review metrics/KPIs/overall health of business and develop strategies to strengthen the partnerships


• Provide front-line support for process- or equipment-related issues at the CDMO and ensure cross-functional engagement internally


• Partner with Process Development, MSAT, and Quality to tech transfer and qualify/ validate manufacturing processes and QC methods


• Assist in contract negotiation and onboarding of new CDMOs

• Travel up to 10% required depending on work location

• Other related duties, as assigned

Qualifications:

• Bachelors’ Degree in life sciences, engineering, business operations, supply chain or related field with MBA preferred


• 6+ years relevant experience in life sciences manufacturing, supply chain management, or external supplier management

• Experience starting up and/or maintaining an external supply chain organization with appropriate tools, and processes

• Experience in biologics or cell/gene therapy preferred


• In-depth knowledge of GMP regulations and a commitment to operational excellence


• Strong project management and organizational skills and experience.


• Proven strong and visible leadership with the ability and influence other functions within the organization

• Strong relationship-building and collaboration skills; able to work effectively with others, both internally and externally, and resolve conflicts.

• Experience designing and implementing business processes to meet departmental and corporate needs


• Respect and value for diverse thinking with the ability to work multifunctionally across a customer-centric organization

• Comfort with ambiguity


• Experience developing structure and processes to operate efficiently and effectively in a dynamic and evolving environment


• 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.

#LI-REMOTE