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    Director/Senior Director - Boston, MA, United States - Scorpion Therapeutics

    Scorpion Therapeutics
    Scorpion Therapeutics Boston, MA, United States

    Found in: Jooble US O C2 - 2 days ago

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    Description
    The position is responsible for technical leadership of analytical development within the CMC function across Scorpion's portfolio.

    Analytical Development has responsibility for analytical activities from late-stage Discovery (lead optimization, development candidate nomination) through early-stage clinical development for small molecule programs.

    They will also be responsible for strategic and scientific alignment of analytical development activities with the overall program needs.

    They should be a leader in the scientific community, capable of effectively managing technical issues with their function and providing expertise throughout the company.

    This individual should actively maintain and champion state-of-the-art scientific and technical knowledge, implementing creative ways to solve challenging problems for new and ongoing projects.

    PhD in chemistry, chemical technologies or related area with 15+ years relevant experience in analytical development roles within the pharmaceutical industry
    Expertise in phase-appropriate small molecule analytical method development and validation
    expertise in analytical laboratory techniques for drug substance and drug product and application of control strategies through all stages of development
    Knowledge and experience of pre-development activities – pre-formulation, solid state, formulations for animal studies
    Demonstrated ability to set clear and measurable goals, managing tasks and resources
    Excellent written and verbal communication skills, organization, and planning skills and a high level of technical aptitude and creativity
    Expertise in all relevant Quality and Regulatory guidelines with the ability to provide mentorship, oversight and review of all relevant Analytical Development source documents for regulatory submission
    Ability to implement new technologies for development programs
    Ability to develop and maintain project plans for internal and external analytical resources, timelines, and budgets
    Proven track record of building strong collaborations and relationships with external CDMOs, internal technical leads and project teams
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