Senior Manager, CMC Project Management

Philadelphia, PA

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. 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. The Company is expected to begin clinical trials for the lead compound for mPV in 2020. Cabaletta Bio is also pursuing a second product candidate, MuSK-CAART, designed to treat patients with MuSK-positive Myasthenia Gravis.

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 to the R&D Operations Director and supporting the future VP Manufacturing at Cabaletta, the CMC Project Manager will drive timely completion of manufacturing supply and CAART production work scopes in line with company strategy, commitments, and goals. This person will manage multiple critical collaborations with vector and cell product contract manufacturing organizations for lead programs and ensure timely completion of projects supporting the supply chain. The CMC PM will partner with project leads within Process Development, Analytics, and Gene Transfer departments to manage the scope, cost, timelines, and quality of development plans across multiple assets.

In this role, the CMC PM will develop detailed project plans, identify interdependences and downstream implications of drug development decisions, and proactively identify and implement risk mitigations.  The CMC project manager will also work closely with the R&D Operations Director, who is responsible for the development and execution of overarching product development plans for the company, in order to ensure continuous alignment on the CMC aspects of these product development plans.  In partnership with functional leaders, the CMC PM will ensure effective stakeholder management, decision governance and communication of project status.

Success in this role depends on strong organizational and interpersonal skills, a keen attention to detail, and a passion for project execution, with the most successful candidates exhibiting strong technical knowledge in the cell therapy CMC space. The PM will be responsible for using best project management practices, tools, and templates.

Responsibilities:

  • CMC Program Planning
    • Deliver on projects that support company objectives within agreed upon time, budget, scope and quality.
    • Collaborate with technical lead and expertise areas (Regulatory Affairs, Manufacturing, Clinical, Supply Chain and Quality) to establish project plans including project scope, goals and deliverables with resource loading and risk mitigation
    • Partner with project lead(s) and Alliance Manager to provide strong team leadership, to negotiate contracts and manage vendor relationships, and to ensure projects supporting company objectives are executed on time and within budget.
    • Assist with development and manage timely delivery of Quality documents for Regulatory submissions
    • Proactively work with R&D Operations to align CMC projects with overall product development plans, implement administrative and organizational processes for future knowledge transfer, and onboard PM tools for efficient tracking and reporting
  • CMC Program Management
    • Proactively monitor the progress of project plans and take accountability to identify and support the resolution of issues and risks, including resource management to ensure success and implementing change control
    • Act as an integrator within the development team and across the organization to ensure alignment and connect best practices
    • Work with internal and external stakeholders to manage project deliverables, e.g. CMO’s, Supply Chain, and support the planning and execution of tech transfers, validations, qualifications and travel to sites as needed
    • senior management
    • Support Quality and Manufacturing leaders in Clinical site qualification for product handling
  • Communication
    • Facilitate effective, science-based business decisions including development of scenarios and drive timely decisions and accountability within the team as needed. Ensure all decisions are assessed as to their impacts and communicated to stakeholders in a transparent and timely manner
    • Curate project-specific correspondences, reports and meeting decks, facilitate/lead cross functional team meetings to manage execution of project plan, including authoring of minutes, assignment of action items and tracking of performance metrics for projects involving CMOs
    • Develop and maintain project planning documents such as project timelines and project-specific files and archive project materials to ensure visibility of both project history, current status, and future directions.
  • Leverage project management best practices to foster a team culture of transparency, accountability, high cross-functional communication, and timely execution.
  • Some travel required (10-20%)

Qualifications:

  • Bachelor's degree in life science-related discipline. Master's degree or higher preferred.
  • 3-8 years of experience in life sciences project management
  • Preference for CMC experience, particularly with programs in early stage clinical trials
  • Cell therapy experience strongly preferred
  • Broad knowledge of project management best practices and proficiency with supporting project management tools; PMP certification required
  • Exceptional planning and organizing skills to plan and manage resources against timelines and commitments; must excel in a dynamic environment.
  • Analytical and problem-solving skills – must be able to troubleshoot critical issues or problems, determine causes and determine and implement solutions.
  • Ability to negotiate and influence partners towards an appropriate path forward.
  • Experience managing cross-functional teams, strong team building / leadership skills
  • Ability to work independently and adapt to various ways of working.
  • Excellent written and oral communication skills.

Our name – Cabaletta – is derived from the operatic term for the second part of an aria that is designed to highlight the technical expertise of the lead singer. While our company is not the first to develop chimeric T cells as therapies, we are the first to develop them in a way that leverages T cells to specifically eliminate only B cells that cause disease, while sparing healthy B cells. Utilizing the backbone of this core technology, we expect to advance our portfolio with a rapid and repetitive rhythm, similar to the rhythm that is typical of a cabaletta.

For more information, please visit https://www.cabalettabio.com/ or email careers@cabalettabio.com directly to submit an application. Please include your CV along with the title of the position you are applying for.

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.