Lead Scientist in Analytical Chemistry and Material Science

2 weeks ago

Boulder, Colorado, United States OnKure, Inc. Full time
Position Overview

Role Summary:
We are in search of a highly skilled and driven Senior Scientist specializing in Analytical Chemistry and Material Science for drug product and substance development. This pivotal role will contribute significantly to the advancement and characterization of small molecule therapeutics targeting oncology. The successful candidate will collaborate extensively with multidisciplinary teams, including medicinal chemistry, DMPK, clinical operations, and pharmacology/biology, throughout the preclinical and clinical phases of our projects. While primarily office-based, the position will involve some laboratory work and occasional travel.


Key Responsibilities:

  • Material Science:
    • Design and execute experiments to analyze the physical and chemical characteristics of drug candidates, including polymorphism, solubility, and stability assessments at contract development and manufacturing organizations (CDMOs).
    • Collaborate with the formulation team to select and advance a solid form of the drug substance for clinical trials (e.g., salts, cocrystals, amorphous formulations).
    • Develop processes for isolating drug substances in partnership with the process chemistry team.
  • Analytical Chemistry:
    • Create and validate robust analytical methods suitable for various phases to characterize drug substances and products, focusing on purity, potency, stability, and impurity profiling.
    • Ensure that methods comply with regulatory standards and industry guidelines (e.g., ICH, FDA, EMA).
    • Establish and justify specifications for drug substances and products.
    • Design and oversee GLP and GMP stability studies to validate material usage periods and expiration dates.
  • External Collaboration and Vendor Management:
    • Identify and select suitable external laboratories and vendors for experimental tasks.
    • Manage relationships with external partners, ensuring effective communication and alignment on project objectives and timelines.
    • Review and negotiate contracts and agreements related to outsourced services.
  • Regulatory Documentation and Compliance:
    • Prepare analytical sections for regulatory submissions, including INDs and NDAs.
    • Ensure adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in all analytical operations.
    • Stay informed on regulatory requirements and guidelines to ensure compliance in all analytical activities.
    • Draft technical reports and scientific publications.
    • Remain updated on advancements in analytical chemistry and material science, applying new methodologies to enhance drug development processes.
    • Contribute to project planning and decision-making in a collaborative environment.

Qualifications:

  • Ph.D. in Analytical Chemistry, Material Science, Pharmaceutical Sciences, or a related discipline with over 5 years of relevant experience in the pharmaceutical or biotechnology sectors; or M.S. with 8+ years of experience; or B.S. with 10+ years of experience.
  • Proficient in analytical techniques and method development, including HPLC, Dissolution, LC-MS, NMR, spectroscopy, and other pertinent methods.
  • Experience in characterizing small molecule compounds, including polymorphism screens, salt and cocrystal screens, and stability studies.
  • Familiarity with regulatory guidelines for analytical method validation and quality control.
  • Demonstrated ability to lead projects and work collaboratively within a multidisciplinary team.
  • Strong analytical and problem-solving skills, with meticulous attention to detail and the ability to work autonomously.
  • Excellent written and verbal communication skills, capable of presenting complex data in a clear and concise manner.

Preferred Qualifications:

  • Experience in the development of oncology therapeutics.
  • Knowledge of solid-state chemistry and material science.
  • Understanding of GMP and GLP regulations.
  • Experience with CMC aspects of drug development.

About OnKure:
OnKure, Inc. is a clinical-stage biopharmaceutical company dedicated to discovering and developing precision medicines targeting biologically validated drivers of cancers that lack effective therapies. Utilizing a structure- and computational chemistry-driven drug design platform, OnKure is committed to enhancing clinical outcomes for patients by building a robust pipeline of small molecule drugs designed to selectively target specific mutations believed to be key drivers of cancer.


OnKure offers a competitive compensation and benefits package, including performance-based bonuses, stock options, comprehensive insurance coverage, self-managed paid time off, and a 401(k) plan with company matching. We are an equal opportunity employer and welcome all qualified applicants.

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