• Director of Pharmaceutical Development

    Astrix Technology (Olmsted County, MN)


    Director of Pharmaceutical Development

     

    Clinical

    Olmsted county, MN, US

    + Added - 19/08/2025

     

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    We are proud to partner with a leading CDMO specializing in pharmaceutical development and manufacturing to hire a Director of Pharmaceutical Development. In this pivotal role, you’ll join a team of experts dedicated to supporting the entire drug development lifecycle from early-stage research to commercial production helping to accelerate the path to market!

     

    **Location:** Olmsted County

    Principal Responsibilities

    + Drive and oversee product development activities at the site, ensuring robust, scalable processes, high-quality results, and on-time delivery of client commitments.

    + Develop, optimize, and enhance small-scale synthesis and formulation processes for small molecules, peptides, and antibodies.

    + Manage CMC documentation to support regulatory submissions and clinical/commercial readiness.

    + Drive innovation through new compounds, delivery methods, and development strategies.

    + Lead, mentor, and develop staff while encouraging a collaborative, high-performing team environment.

    + Partner with leadership and project teams to establish project plans, timelines, budgets, and key deliverables.

    + Assist in deviation investigations and ensure compliance with GMP and regulatory requirements.

    Qualifications & Requirements

    + Ph.D. in Chemistry, Biochemistry, or a related scientific discipline.

    + Minimum of 5 years of experience in pharmaceutical/biotech product development involving small molecules, peptides, or antibodies.

    + Proven leadership experience, including team management and mentorship.

    + Experience in preparing CMC documentation for regulatory submissions (e.g., IND, NDA).

    + Strong knowledge of GMP standards and pharmaceutical manufacturing practices.

    + Demonstrated success in delivering projects in fast-paced, innovative environments.

    + Flexible and adaptable, including willingness to work extended hours when needed.

    + Passion for innovation and continuous improvement in product development.\#INDBH

     

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.