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Job Description - CMC Team Leader, Sr. Director

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

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

Job Description - CMC Team Leader, Sr. Director

Reports to: Head of Technical Operations
Location: [Remote]
Department: Technical Operations / CMC

Position Summary

We are seeking an experienced and strategic CMC Team Leader to provide cross-functional leadership for Chemistry, Manufacturing, and Controls (CMC) activities across clinical and commercial-stage biologic products. This individual will serve as the integrated CMC lead for our late-stage autologous cell therapy programs and will partner closely with Technical Operations, Process Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and Program team lead to advance products from development through commercialization.

The ideal candidate is a scientifically strong and operationally experienced leader with prior end-to-end CMC leadership experience, including regulatory submissions and late-stage/commercial readiness activities. Experience in biologics is required, with cell and gene therapy experience strongly preferred.

This role reports directly to the Head of Technical Operations and will play a key role in shaping CMC strategy, execution, and organizational excellence.

Key Responsibilities

CMC Strategy & Program Leadership

• Lead the overall CMC strategy for assigned program(s) from development through registration and commercialization.
• Serve as leader of the cross-functional CMC team, aligning activities across Process Development, Analytical Development, Quality, Regulatory, and Supply Chain to deliver to program objectives.
• Develop integrated CMC development plans including process development, analytical development, manufacturing, comparability, process characterization, validation, and lifecycle strategy.
• Drive cross-functional decision-making on technical risks, timelines, development priorities, and resource needs.
• Ensure CMC plans are aligned with clinical, regulatory, and commercial objectives.

Regulatory & Filing Support

• Partner with Regulatory Affairs to develop the CMC regulatory strategy for global submissions.
• Provide CMC leadership and content oversight for IND/CTA amendments, BLA/MAA filings, responses to agency questions, and post-approval changes.
• Lead preparation for health authority interactions related to CMC.
• Ensure consistency between technical development strategy and regulatory submission strategy.

Commercialization & Lifecycle Readiness

• Support planning and execution of commercialization readiness activities including process validation, PPQ/CPV strategy, control strategy, and manufacturing readiness.
• Provide strategic leadership for CMC aspects of launch readiness, supply continuity, and lifecycle management.
• Support technical transfer, process scale-up, and manufacturing network strategy as applicable.

Cross-Functional Leadership

• Partner closely with:
• Process Development / MSAT
• Analytical Development
• Quality Assurance / Quality Control
• Regulatory Affairs
• Supply Chain
• Program Management
• Project Management
• Drive alignment across internal teams and, if needed, external CDMO partners.
• Escalate key risks, tradeoffs, and recommendations to senior leadership in a concise and actionable manner.

Governance & Communication

• Lead CMC team meetings, governance forums, and strategic planning discussions.
• Develop clear executive-level summaries of program status, risks, mitigation plans, and critical path activities.
• Present program updates to leadership, governance committees, and external stakeholders as needed.

Qualifications

Required

• Advanced degree in life sciences, chemical engineering, biochemical engineering, pharmacy, or related discipline (PhD, MS, or equivalent preferred).
• 12+ years of relevant CMC experience in biotechnology or pharmaceutical development.
• Prior experience serving as a CMC Lead or equivalent cross-functional program CMC leadership role.
• Strong background in biologics development including process development, analytical development, manufacturing, and regulatory strategy.
• Experience leading cross-functional teams in a matrixed development environment.
• Demonstrated ability to develop integrated CMC strategy across development stages.
• Strong understanding of GMP manufacturing, product/process development, and regulatory expectations for biologics.
• Excellent communication skills with ability to communicate technical strategy clearly to both technical and executive audiences.

Preferred

• Experience supporting commercialization, BLA/MAA submission, or commercial launch activities.
• Experience with cell and gene therapy products, including autologous or complex biologic modalities.
• Experience with process validation, comparability, control strategy, and lifecycle management.
• Experience in late-stage clinical or pre-commercial biotech environment.

Leadership Competencies

• Strategic and scientifically rigorous thinker
• Strong cross-functional influencer and collaborator
• Comfortable operating in fast-paced, evolving biotech environments
• Able to balance technical depth with execution focus
• Strong judgment in navigating ambiguity, risk, and competing priorities
• Clear communicator with executive presence
• Patient-focused with commitment to quality, innovation, and reliable execution

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