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Associate Director, Small Molecule Analytical Development

Associate Director, Small Molecule Analytical Development

Otsuka Pharmaceutical Co.Princeton, NJ, United States
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Associate Director, Small Molecule Analytical Development

  • Lead and oversee phase appropriate method development and optimization for drug substance and drug product at CDMOs
  • Design and lead method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines
  • Develop and implement stability study protocols and timelines, including sample collection, storage conditions, and analytical testing, to support product development and regulatory submissions.
  • Author and review INDs, NDAs, and other regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements.
  • Perform holistic analysis of the analytical projects including logistics, budgeting, method development through release testing and reporting, providing actionable insights and recommendations to optimize project outputs for the project teams and ensure alignment with the strategic objectives. Monitor progress, identify potential risks, and implement appropriate mitigation strategies.
  • Mentor and train team members on stability study design, execution, and data analysis techniques, fostering their professional growth and expertise in pharmaceutical stability studies.
  • Collaborate cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs, quality assurance, and other departments to drive scientific excellence, resolve complex technical issues, and ensure compliance with applicable regulations and guidelines.
  • Provide CMC functional representation on wider cross-functional program development teams, ensuring all CMC considerations are accounted for in wider clinical development plans.
  • Serve as early-stage CMC representative of the department in effectively communicating program related updates, strategies, and initiatives to key stakeholders and senior management.
  • Develop and manage comprehensive budgets for various projects ensuring financial resources are effectively allocated and aligned with strategic objectives.

Qualifications

  • BS or MS in Analytical Sciences, Chemistry, or related field with a minimum of 12 years of experience in the biopharmaceutical industry
  • PhD in Analytical Sciences, Chemistry, or related field with a minimum of 7 years of experience in the biopharmaceutical industry
  • Direct experience in the biopharmaceutical industry working in drug substance and drug product small molecule method development, validations and implementations. Experience must include time in a GMP environment.
  • Prior experience overseeing and working with external manufacturing and analytical sites
  • Expertise in chromatographic (HPLC, UPLC, GC) and spectroscopic (MS, UV / Vis, FTIR), and other analytical techniques.
  • Strong leadership, communication (written and verbal), and interpersonal skills, with the ability to influence and collaborate effectively with internal and external stakeholders.
  • Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment
  • Deep knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards.
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