Our RESETTM clinical trials with CABA-201 (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris are now recruiting.

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

Philadelphia, PA

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 Include

  • 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.

Required 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.


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How to Apply

Please click the link at the bottom of the posting to submit an application.

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.