Director / Sr. Director, Project Management, Technical Operations (Hybrid) 

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® 

 

About the Position: 

This role is located in Center City, Philadelphia. We are a hybrid work environment, and the expectation is that this role will be in the office 2-3 days per week, with the remainder of the week remote. 

 

Reporting to the VP, Portfolio & Program Management, the Director / Senior Director – Project Management, Technical Operations will support the strategic planning, coordination, and execution of CMC activities across all stages of product development and commercialization. This role operates within the broader centralized Portfolio Management Organization (PMO) and involves close collaboration with cross-functional teams beyond CMC and supply, including preclinical and translational research, clinical, regulatory affairs, and quality assurance.   

The Director / Senior Director, Project Management, Technical Operations must have extensive experience in CMC project management, excellent leadership skills, and an understanding of the interdependent relationships between regulators, technology development, clinical plans, manufacturing processes and product lifecycle, to successfully deliver on their responsibilities within the PMO.  The individual is responsible for ensuring all TechOps activities are robustly mapped out and continuously updated, with risk registers driving contemplation of contingency scenarios.  Working as an integrated member of the CMC LT, this role will ensure that the program plans of CMC and supply, which are uniquely critical path for an autologous cell therapy product, are aligned with the overall project timelines and corporate objectives, driving the development and commercialization of high-quality, safe, and effective therapies. 

 

Responsibilities: 

  • Schedule and lead team meetings including developing agendas, publishing meeting minutes and decision logs, and tracking action items to completion. 

  • Initiate and maintain cross-functional collaboration and communication, as needed, to drive project progress and team alignment. 

  • Prepare and present slide decks, project reports and updates to senior management and other key stakeholders to inform and drive decision making. 

  • Work with CMC Leadership Team to provide scenario planning and project reporting for all CMC project management activities, aligning them with company goals and regulatory requirements, including the development and maintenance of charters, dashboards, trackers, schedules and other PM documentation. 

  • Routinely perform project planning and due diligence including development of projected scopes,  timelines, budgets, and resource plans to contributing Technical Operations project portfolio. 

  • Extensively support ongoing program management initiatives by utilization and/or creation of project management tools and templates across the company contributing to a continuous improvement culture. 

  • Work with the lead Asset PM to support our cross-functional Product Development Team Program (PDT) and the CABA-201 clinical program. 

  • Work closely with Regulatory Affairs, CMC Technical Development, Quality & Compliance, and Supply Chain to support the preparation and submission of regulatory filings, including INDs, and BLAs. 

  • Work with all appropriate stakeholders to identify potential project risks, maintain risk registers, conduct risk assessments and develop mitigation strategies to address them proactively. 

  • Be a strategic partner with Finance, Alliance Management and Legal teams to quickly resolve issues, and facilitate on-time, on budget delivery of project milestones. 

  • Work across time zones as necessary. 

  • Travel 10-15% may be required. 

  • Other duties as assigned. 

 

SmartSheet Management: 

  • Utilize SmartSheet for project planning, tracking, and reporting both within a singular project and across multiple projects/programs creating one unified portfolio summary/report 

  • Create, maintain, and publish SmartSheet dashboards and reports for project status updates. 

  • Work with the PMO team to ensure that all department timelines and risk trackers integrate within the overall corporate portfolio and integrated roadmaps. 

  • As SmartSheet Super User, train and support team members on SmartSheet use, management, and reporting as well as other functionalities, as needed. 

 

Qualifications: 

  • Experience in pharmaceutical or biotechnology industries is required. 

  • Advanced degree in Life Sciences is preferred. 

  • 10+ years of experience in technical operations, CMC project/program management experience required, C&GT, CAR-T or similar industry preferred. 

  • Experience in manufacturing tech transfer preferred. 

  • Certification in project management (e.g., PMP, CAPM) is preferred. 

  • Experience with both early- and late-stage clinical programs is an advantage. 

  • Proficiency in MS Office (MS Outlook, PowerPoint, Excel, and Word); familiarity with project management tools is required. 

  • Strong understanding of PM Best Practices, operating in a PMO and how to scale processes in a growing corporate environment is required. 

  • Extensive experience in utilization of Smartsheet including creation, maintenance, and reporting of timelines, Gantt charts, dashboards, and reports.  

  • Excellent external facing representation and experience in managing vendor relationships and contracts. 

  • Excellent verbal and written communication skills. 

  • Outstanding attention to detail with the ability to manage multiple tasks and priorities. 

  • Excellent strategic planning skills. 

  • Ability to work both independently and collaboratively with cross-functional teams. 

  • Thrives in a dynamic, fast-paced, timeline-based environment. 

  • Strong customer service focus as part of a centralized PMO function. 

  • Strong team orientation and passion for continuous self-development. 

  • Experience in a startup industrial setting is preferred. 

 

 

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.