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    Remote VP of Technology - Boston, MA, United States - Odyssey Therapeutics, Inc.

    Odyssey Therapeutics, Inc.
    Odyssey Therapeutics, Inc. Boston, MA, United States

    2 weeks ago

    Default job background
    Description

    Odyssey Therapeutics is propelling drug development beyond what is now possible to deliver medicines that address critical needs of patients with inflammatory diseases and cancer.

    We achieve unprecedented speed and efficiency by bringing together a target-centric approach, a toolbox of cutting-edge technologies, and a team of accomplished, world-class drug hunters.

    By reimagining the drug development process, we are creating a deep and broad drug pipeline that holds the potential to transform human health.


    Employment Type:
    Full-Time, Hybrid

    The candidate will be responsible for phase appropriate CMC development and manufacturing strategies, due diligence, identifying and implementing necessary process improvements, oversight of activities at contract development and manufacturing organizations (CDMOs), as well as authoring/review of relevant submissions to regulatory agencies.

    Technical depth and a broad understanding of chemical process, analytical and formulation development.
    Be the functional area representative for Drug Substance and Drug Product on project teams

    Establishment and oversight of activities, including process optimization, solid-state and formulation development, API and drug product manufacturing at external laboratories and manufacturing facilities.

    Ability to scale out a team commensurate with the overall organizational growth – FTEs when needed and contractors to fill gaps
    Development and implementation of phase appropriate CMC development and manufacturing strategies from early clinical to commercial stages
    Identification of necessary process improvements, and management of development/ implementation of process improvements at external manufacturing sites.

    In coordination with Clinical Operations, Project Management and external CDMOs, forecasting of manufacturing needs and scheduling of manufacturing runs in accordance with program timelines and budgets.

    Interaction as process development and manufacturing leader with internal and external parties, including Program Management, Analytics, Regulatory Affairs, and Quality Assurance.

    Identification and communication of risks in the manufacturing process and their mitigation.

    Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, reports, regulatory filings, or other controlled documents, as needed.

    Contribute to building and maintaining phase-appropriate Quality infrastructure in support of external CMC operations
    Act as process and technical expert during regulatory interactions
    Representation of the company as overall manufacturing process expert during diligence and partner company interactions.

    Doctorate in Chemistry or related discipline, with 15+ years of experience in manufacturing and CMC activities within the Biotechnology or Pharmaceutical industry, with significant experience in the field of small molecule drug development.

    Expertise overseeing the design of new syntheses and process improvements to achieve bulk and quality goals, to ensure that API processes and manufacture of Drug Substance can be successfully accomplished.

    Experience with solid oral dosage form development with expertise in the interplay between formulation modality and in vivo performance. Proficient in the management of Contract Manufacturing Organizations, leading GMP manufacturing activities, and managing drug supply for clinical studies
    Operational experience and familiarity with the drug development process, including external regulatory requirements and cGMP. CMC project leadership experience is a plus.
    Well versed in authoring and reviewing CMC sections of regulatory dossiers, and interactions with global regulatory agencies.

    Oversight and knowledge in interacting and coordinating efficiently with Clinical Development, Clinical Operations, Non-Clinical, Analytics, Regulatory Affairs, Program Management, Quality Assurance, and Commercial.

    Expertise in early development as well as late stage/commercial small molecules, preferably in direct management of multiple disciplines and platforms.

    Experience managing a diverse team.
    Strong initiative, accountability and willingness to take ownership and drive projects to completion.
    A track record of achieving results in a virtual/outsourced model.
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