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Director, Manufacturing Operations

Philadelphia, PA

About the Position

The Director, Manufacturing Operations, reporting into the Head of Manufacturing, will be responsible for set up and oversight of our in-house cell therapy manufacturing activities for clinical and future commercial-stage activities. This position will work very closely with internal manufacturing and analytic sciences, quality, and development teams, as well as external CDMO partners for successful development and commercialization of Cabaletta’s products.

Responsibilities Include

  • Partner with Manufacturing Sciences and Technology (MSAT) and Process Development (PD) teams to ensure excellence in manufacturing performance and technology transfer, including batch record development, SOP generation, and operator training.
  • Provide oversight of personnel in plant at CDMOs, ensuring fidelity of process across all manufacturing sites.
  • Facilitate internal and cross-functional stakeholders to drive strategic decisions for manufacturing operations execution.
  • Direct day to day operations and hands-on management of manufacturing technical operations and supply teams.
  • Ensure appropriate review of production batch records and support deviations, CAPA’s, Change Controls, and Investigations in collaboration with Quality and MSAT functions.
  • Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver on cell and vector supply in accordance with demand plans.
  • Manage cell therapy and vector supply chain:
  • Forecast, schedule, and track manufacturing activities.
  • Ensure right first-time delivery of cell products to clinical sites.
  • Ensure site personnel are appropriately trained for product handling, storage, thaw and infusion.
  • Support start-up of equipment, resources, and facility for future in-house cell therapy cGMP manufacturing capabilities.
  • Develop in-house systems and tools for manufacturing compliance. Work with internal and external stakeholders to establish EHS guidelines.
  • Partner with Head of Regulatory on CMC regulatory submissions.
  • Participate in BLA planning and execution of readiness activities.

Required Qualifications

  • BS in related science field or engineering required, and MS preferred
  • Minimum of 10+ years of GMP manufacturing experience within biologics and/or cell and gene therapy products.
  • Minimum of 3 + years of cell therapy product development with a solid working knowledge of T-cells or immunological cell therapies preferred.
  • Experience with cell therapy manufacturing scale up, technology transfer, and process development and optimization is required.
  • Concrete working knowledge in cGMP, ICH and FDA regulations for biologic products.
  • Proven communication and collaboration in smaller team settings.
  • 3-5 years of team management is required.
  • Previous start-up biotech and/or starting up a manufacturing facility is a plus.

How to Apply

Please email careers@cabalettabio.com directly to submit an application.

Please include your CV along with the title of the position you are applying for.

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.