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    Director of Manufacturing - Watertown, United States - Landmark Bio

    Landmark Bio
    Landmark Bio Watertown, United States

    3 weeks ago

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    Description
    Landmark Bio translates groundbreaking research into life-changing medicines.

    We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic.

    Launched in 2021, and based in Watertown, Mass.

    Landmark Bio is an unprecedented venture bringing together the best of industry, academia and research hospitals to accelerate life sciences innovation.

    A public benefit company, our work advances emerging technologies, demonstrates therapeutic potential, and improves human health.

    We are seeking a highly motivated and team-oriented professional with entrepreneurial spirit to join our company This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning today's cutting-edge research into tomorrow's breakthrough therapies.

    You'll lead a dynamic cross-functional team in producing clinical supply products under cGMP conditions. Your responsibilities include ensuring safe, high-quality, and efficient product delivery while fostering employee development and engagement. You'll play a pivotal role in establishing and optimizing Viral Vector and Fill Finish Operations during the start-up phase. As a member of the Tech Ops Leadership Team, you'll contribute to strategic planning and cross-functional collaboration.
    Scope of Responsibilities

    • Lead a cross-functional Production Team to produce clinical supply products under cGMP conditions in a Lean Manufacturing environment.
    • Directly responsible for safe, high-quality, compliant, and efficient product delivery, as well as financial diligence.
    • Develop and mentor employees to foster a culture of engagement, learning, and growth.
    • Establish philosophies, operability, and business processes for the GMP manufacturing area and team during the start-up phase.
    • Participate in the start-up project team to provide expertise on GMP, lean operations, and efficient production scheduling.
    • Serve as designated Technical Lead for facility start-up or New Product Introduction projects.
    • Oversee manufacturing team training and development to create a high-performance culture.
    • Ensure manufacturing area readiness for production and GMP audits.
    • Drive continuous improvement activities and support organizational development.
    • Partner with Quality Assurance to develop and implement quality systems aligning with regulatory standards.
    • Monitor performance against production goals and identify and resolve gaps.
    • Communicate effectively with internal and external stakeholders, including senior management.
    Qualifications

    • Bachelor's degree in Science/Engineering preferred.
    • Experience in pharmaceutical/biotechnology operations, specifically in advanced therapies manufacturing.
    • Strong understanding of GMP.
    • 5+ years of team leadership experience.
    • Experience hosting regulatory audits and developing audit presentations.
    • Demonstrated experience in Lean Manufacturing environment.
    • Project leadership skills and ability to develop effective working relationships.
    • Ability to make impactful decisions and foster a culture of innovation.
    • Strong communication and interpersonal skills.
    • Additional experience in related functional areas outside of manufacturing is a plus.
    Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
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