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    Senior Scientist - Gaithersburg, United States - Meet

    Meet
    Meet Gaithersburg, United States

    4 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Are you ready to lead a team of dynamic scientists and drive the development of cutting-edge pharmaceutical products? Meet's global biopharmaceutical client is looking for a Senior Scientist to spearhead their Formulation Development department. As the ideal candidate, you'll have a proven track record in leading drug substance and drug product formulation projects, guiding them from initial candidate identification through to commercialization.

    Key Responsibilities:

    • Lead and manage a team in the characterization, development, and evaluation of recombinant protein vaccine products.
    • Design and execute scientific formulation activities for preclinical and early clinical studies, utilizing Quality by Design (QbD) and Design of Experiment (DOE) principles.
    • Develop adjuvanted and unadjuvanted formulations of recombinant protein nanoparticle vaccines.
    • Collaborate cross-functionally to provide scientific expertise and support product development teams.
    • Participate in process development, scale-up activities, and technology transfers.

    Minimum Requirements:

    • PhD in relevant field with 6 years of scientific experience, or Master's degree with a minimum of 10 years of relevant experience.
    • Demonstrated leadership in project management, with experience managing teams and motivating scientists.
    • Expertise in formulation product development, Quality by Design (QbD), and Design of Experiment (DOE) processes.
    • Direct experience in recombinant protein drug substance synthesis, characterization, evaluations, and formulation development.
    • Strong analytical skills, including statistical analysis and technical report compilation.
    • Knowledge of GLP and GMP requirements, with experience in regulatory submissions.
    • Proficiency in bio/analytical and physicochemical characterizations of proteins is highly desirable.
    • Excellent problem-solving skills, ability to work independently, and strong record-keeping abilities.
    • Outstanding technical writing skills with a history of scientific publications.
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