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    Senior Manager, Network Management - Boston, MA, United States - Apex Systems

    Apex Systems
    Apex Systems Boston, MA, United States

    3 weeks ago

    Apex Systems background
    Description
    Manager/Senior Manager, CMC, Drug Product
    Manager/Senior Manager, CMC, Drug Product

    Job Overview:

    Seeking a Manager/Senior Manager CMC to oversee the outsourced process development and cGMP manufacturing campaigns for Drug Product of small molecule drug development programs.

    Lead and manage multiple concurrent CMC Drug Product projects at CDMOs, including formulation development, process optimization and validation, cGMP manufacturing campaigns, and scale-ups and technology transfer.

    Oversee process scale-up activities to meet forecasted commercial demand as programs progress through development.

    Collaborate with internal and external teams to research, develop, and test processes, analytical methods, and controls for drug product development, and recommend and select vendors for relevant projects.

    Manager/Senior Manager, CMC, Drug Product

    Job Overview:

    Seeking a Manager/Senior Manager CMC to oversee the outsourced process development and cGMP manufacturing campaigns for Drug Product of small molecule drug development programs.

    Lead and manage multiple concurrent CMC Drug Product projects at CDMOs, including formulation development, process optimization and validation, cGMP manufacturing campaigns, and scale-ups and technology transfer.

    Oversee process scale-up activities to meet forecasted commercial demand as programs progress through development.

    Collaborate with internal and external teams to research, develop, and test processes, analytical methods, and controls for drug product development, and recommend and select vendors for relevant projects.

    PhD or MS in Chemistry, Pharmaceutical Sciences, or Chemical Engineering.

    Possess a minimum of 5 years' experience in the pharmaceutical industry, with a focus on formulation, process development, and cGMP manufacturing of solid oral dosage drug product.

    Demonstrate experience and proficiency in working, collaborating with, and managing CDMOs.
    Good understanding of cGMP drug product manufacturing guidelines under US and EU regulatory agencies
    Previous experience with writing and supporting CMC regulatory submissions including IND and CTA

    Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member.

    PROVEN SCIENTIFIC PLACEMENT

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

    If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

    We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

    If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at .We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package.

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