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    Senior - Philadelphia, United States - Cabaletta Bio

    Cabaletta Bio
    Cabaletta Bio Philadelphia, United States

    1 week ago

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    Description
    Senior Director Manufacturing Data Science and Technology (MDS&T)

    Philadelphia, PA

    About the Position


    As a Senior Director, Manufacturing Data Science and Technology (MDS&T), you will play a pivotal role in leading and overseeing the end-to-end manufacturing, technology transfer and refinement of scalable cell therapy production processes.

    This position demands a deep understanding of cell therapy processes, a strong background in bioprocessing, and the ability to drive innovation while ensuring regulatory compliance.


    The Senior Director, MDS&T plays a critical role in advancing cutting-edge therapies that have the potential to transform patient care.

    This position requires a combination of technical expertise, leadership, and a commitment to excellence in process development.

    Responsibilities Include


    • Develop and execute the overall MDS&T strategy for cell therapy products, aligning it with the company's objectives and growth plans.
    • Provide leadership and direction to cross-functional teams, fostering collaboration, and driving process innovation.
    • Drive technology transfer planning and execution across manufacturing network.
    • Ensure the scalability and robustness of processes to meet commercial production requirements.
    • Maintain a deep understanding of relevant regulatory guidelines and ensure that all process development activities adhere to regulatory standards (e.g., FDA, EMA).
    • Collaborate with regulatory affairs to support submissions and inspections.
    • Build a best-in-class MDS&T team through recruitment, mentoring, and managing a team high-performing team of scientists and engineers in process development.
    • Set clear objectives, provide guidance, and foster professional development.
    • Facilitate the successful transfer of processes from development to manufacturing teams, ensuring seamless scale-up and technology transfer activities.
    • Collaborate with cross-functional teams, including manufacturing, quality, research, and clinical development, to achieve project milestones and goals.
    • Communicate progress and findings to senior leadership and stakeholders.
    • Manage the budget and allocate resources efficiently to support process development projects.
    • Ensure cost-effective strategies while maintaining quality standards.
    • Identify potential risks in the development process and implement mitigation strategies to ensure product success and patient safety.
    • Drive a culture of continuous improvement, implementing new technologies and best practices to enhance process efficiency and product quality.
    Required Qualifications


    • M.S. or equivalent in bioengineering or a relevant scientific discipline (e.g., cell biology, biotechnology).
    • 15+ years' experience in process development within the cell therapy industry.
    • Strong knowledge of cell therapy manufacturing processes, including cell culture, cell expansion, gene editing, and downstream processing.
    • Proven leadership and team management skills, with a track record of building and leading high-performing teams.
    • Deep understanding of cGMP regulations and experience in regulatory interactions and submissions.
    • Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
    • Results-oriented mindset with a focus on achieving project goals and timelines.
    • Strong problem-solving skills and the ability to adapt to changing priorities in a dynamic environment.
    • Experience in technology transfer and process scale-up is a plus.
    Apply For This Job
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