Director/Senior Director,CMC lead - Boston - WuXi XDC

    WuXi XDC
    WuXi XDC Boston

    1 week ago

    Description

    WuXi XDC (stock code: 2268.HK), a leading Contract Research, Development and Manufacturing Organization (CRDMO) focused on the global antibody drug conjugates (ADCs) and broader bioconjugate market, is a pioneering CRDMO offering integrated, end-to-end services. Services are provided from proximately located, state-of-the-art laboratories and manufacturing facilities, allowing for a significant reduction in development timelines and costs. Headquarter in Shanghai, China, our over 1,000 skilled employees work across a global network to deliver expert-driven, high-quality and right-first-time project execution for our customers. By offering a single-source, open-access platform with the most comprehensive capabilities and technologies, WuXi XDC enables our biopharmaceutical partners to speed the development of innovative therapies for the benefit of patients worldwide.

    About the job


    Summary


    The incumbent will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical teams and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting WuXi XDC's services at conferences/trade shows.

    This position will offer the candidate flexibility working remotely from home in US or EU locations. Relocation to China could be an option.

    Responsibilities

    • Provide project and portfolio leadership supporting IND-enabling early and late stage bioproduct development CMC activities.
    • Collaborate with CMC functional areas to ensure successful execution of various ADC or bioconjugate CMC projects, and delivery of results on time and within budget.
    • Assist with development and manufacturing alliance management, product development and manufacturing strategy.
    • Coordinate efforts and facilitate communication to ensure alignment between WuXi XDC and clients.
    • Work with a high-performance team to ensure best quality services.
    • Enhance current service offering and develop new clients.

    Technical Skills / Knowledge


    The candidate should possess strong and effective project management, problem solving and interpersonal skills, and have a proven track record of working cross-functionally, across a wide variety of technical, business, and operational areas.

    Demonstrate good understanding of the pharmaceutical industry and large molecule drug development.

    • The title of this CMC Lead position is flexible and may be from Associate Director, Director up to Senior Director.
    • Depending upon the title, minimal 5-20 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing is required.
    • Working knowledge and understanding of current regulations and industry trends for large molecule and ADC/bioconjugate product development, manufacture, and testing is a must.
    • Working experience in ADC is preferred.
    • Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.

    Customary Education and Experience

    • MS/PhD in biochemistry, molecular biology, biochemical engineering, pharmaceutical science or related discipline.
    • Fluent in English and Mandarin Chinese.
    • Must have working knowledge of MS Office products.
    • Technical experience at large pharma or biotech companies.
    • ADC/Biologics process/formulation/analytical development and/or manufacturing experience

    #J-18808-Ljbffr

  • CMC Regulatory Lead

    1 month ago

    Only for registered members Boston

    We are seeking an experienced CMC Regulatory Lead to provide strategic and operational leadership for all Chemistry, Manufacturing, and Controls (CMC) regulatory activities. · Develop and execute global CMC regulatory strategies to support IND, CTA, NDA/BLA, and lifecycle submiss ...

  • Biologics CMC Lead

    1 month ago

    Only for registered members Cambridge

    This role is accountable for developing the vision strategy and implementation of drug substance and drug product CMC strategies for The Company's portfolio programs and oversees matrix leaders who govern the success of technical development as a whole. · The role also oversees a ...

  • Biologics CMC Lead

    1 month ago

    Only for registered members Cambridge, MA

    Rhapsogen is a biotechnology company that develops precision biologics for autoimmune diseases. As Biologics CMC Lead, you will develop the vision and strategy for drug substance and drug product CMC strategies. · ...

  • Director, CMC Team Lead

    1 month ago

    Only for registered members Boston

    This Is What You Will DoThe Director, CMC Team Lead is a strategic leader within the Product Development and Clinical Supply (PDCS) organization within Alexion R&D. · ...

  • Director, CMC Asset Lead

    1 month ago

    Only for registered members Cambridge

    The Pharmaceutical Operations and Technology (PO&T) Division is seeking to fill a key member of the Asset Development & Portfolio Management (ADPM) team. · This role oversees one or more programs in pre-clinical to Phase 2 stages and may manage corporate partners.This position is ...

  • Director, CMC Asset Lead

    1 month ago

    Only for registered members Cambridge Full time

    The Pharmaceutical Operations and Technology (PO&T) Division is seeking to fill the position of CMC Asset Lead. This role is a key member of the Asset Development & Portfolio Management (ADPM) team, which is responsible for providing cross-functional leadership for development pr ...

  • Director, CMC Asset Lead

    5 days ago

    Only for registered members Cambridge, MA

    The Pharmaceutical Operations and Technology (PO&T) Division is seeking to fill the position of CMC Asset Lead. · The PO&T Asset Lead will oversee one or more programs in pre-clinical to Phase 2 stages and may be required to manage corporate partners.An advanced degree (PhD prefe ...

  • Director/Senior Director,CMC lead

    1 month ago

    Only for registered members Boston, MA Remote job

    About WuXi XDC is a leading Contract Research Development and Manufacturing Organization focused on the global antibody drug conjugates ADCs and broader bioconjugate market. · The incumbent will lead the orderly progression of projects from proposal stage through project completi ...

  • Senior Director, CMC Technical Lead

    2 weeks ago

    Only for registered members Boston, MA

    Elektrofi is seeking an experienced CMC Technical Lead to join our Program Management and Portfolio Strategy team. · ...

  • Director/Senior Director,CMC lead

    1 month ago

    Only for registered members Boston

    About WuXi XDC we are looking for a CMC lead to manage our projects from proposal stage through project completion. This position will offer flexibility working remotely in US or EU locations. · The incumbent will lead the orderly progression of projects. · ...

  • Senior Director, CMC Technical Lead

    1 month ago

    Only for registered members Boston $235,000 - $285,000 (USD)

    Elektrofi is seeking an experienced CMC Technical Lead to join our Program Management and Portfolio Strategy team. · This role will serve as the primary technical and strategic interface between internal cross-functional teams, external partners, and regulatory authorities to ens ...

  • GRA CMC Lead

    1 month ago

    Only for registered members Framingham, MA

    We're an R&D-driven,AI-powered biopharma company committed to improving people's lives and delivering compelling growth. · Our deep understanding of the immune system –and innovative pipeline– enables us to invent medicines and vaccines that treat and protect millions of people a ...

  • GRA CMC Lead

    1 month ago

    Only for registered members Framingham

    As GRA CMC Lead within our GRA CMC & GRA Device Organization, you'll drive global regulatory strategies for pharmaceutical and vaccine products. · ...

  • Global Regulatory CMC Lead

    3 weeks ago

    Only for registered members Waltham

    We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. · ...

  • Global Regulatory CMC Lead

    3 weeks ago

    Only for registered members Waltham Full time

    The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development. · ...

  • Associate Director, Regulatory CMC Small Molecule Lead

    1 week ago

    Only for registered members Cambridge Full time $155,000 - $214,000 (USD)

    As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen's small molecule portfolio. · ...

  • Global Manufacturing Sciences CMC Lead

    1 week ago

    Only for registered members Lexington

    Join us as our Global Manufacturing Sciences CMC Leadand drive high-impact, high-visibility CMC projects for innovative biologics in a dynamic global environment. · ...

  • CMC Senior Project Lead, Global Biologics Manufacturing Sciences

    1 month ago

    Only for registered members Lexington $137,000 - $215,270 (USD)

    We are seeking a Senior Project Lead to join our Global Biologics Manufacturing Sciences team. In this role you will provide project management expertise for strategic initiatives and Chemistry, Manufacturing and Controls (CMC) Life Cycle management (LCM) activities. · Co-lead CM ...

  • Senior Vice President CMC Regulatory Affairs

    1 month ago

    Only for registered members Boston

    We are seeking a highly experienced Senior Vice President, CMC Regulatory Affairs to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. · This role is designed for a recognized subject matter exp ...

  • Vice President, Regulatory Affairs, CMC

    5 days ago

    Only for registered members Boston

    We are seeking a highly experienced Vice President, Regulatory Affairs, CMC to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. · We seek a recognized subject matter expert in Regulatory Affair ...

  • Senior Director, CMC – Small Molecules

    5 days ago

    Only for registered members Boston

    +We are seeking a Senior Director to lead end-to-end Chemistry Manufacturing and Controls strategy for a growing small-molecule pipeline.+ · +PhD in Chemistry Chemical Engineering Pharmaceutical Sciences or related field · 10+ years of increasing responsibility leading CMC for s ...

Jobs
>
Boston