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Lead Analytical Chemist and Material Scientist

2 months ago

Boulder, Colorado, United States OnKure, Inc. Full time
Job Summary

We are seeking a highly skilled and experienced Senior Scientist to join our PharmSci team at OnKure, Inc. The successful candidate will play a key role in the development and characterization of small molecule oncology therapeutics.

Key Responsibilities
  • Material Science:
    • Design and conduct experiments to characterize the physical and chemical properties of drug candidates, including polymorphism, solubility, and stability studies at Contract Development and Manufacturing Organizations (CDMOs).
    • Collaborate with the formulation group to advance and nominate a solid form of the drug substance to be advanced to the clinic, including salts, cocrystals, and amorphous formulations.
    • Develop a process for the isolation of the drug substance in collaboration with the process chemistry group.
  • Analytical Chemistry:
    • Develop and validate robust and phase-appropriate analytical methods to characterize drug substances and drug products, including assays for purity, potency, stability, and impurity profiling.
    • Ensure methods are suitable for regulatory submissions and comply with industry standards and guidelines, such as ICH, FDA, and EMA.
    • Propose and justify specifications for drug substance and drug product.
    • Design and monitor Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) stability studies to justify material use periods and expiration.
  • External Collaboration and Vendor Management:
    • Identify and select appropriate external laboratories and vendors for experimental work.
    • Manage relationships with external partners, ensuring clear communication and alignment on project goals and timelines.
    • Review and negotiate contracts and agreements related to outsourced services.
  • Regulatory Documentation and Compliance:
    • Prepare analytical sections of regulatory submissions, including Investigational New Drug (IND) applications and New Drug Applications (NDAs).
    • Ensure compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in all analytical activities.
    • Stay updated on regulatory requirements and guidelines to ensure that all analytical work meets current standards.
    • Prepare technical reports and scientific publications.
    • Stay current with advancements in analytical chemistry and material science and apply new techniques and methodologies to improve drug development processes.
    • Work in a collaborative environment, contributing to project planning and decision-making.
Requirements
  • Education:
    • Ph.D. in Analytical Chemistry, Material Science, Pharmaceutical Sciences, or a related field with 5+ years of relevant experience in the pharmaceutical or biotechnology industry; or M.S. with 8+ years of experience; or B.S. with 10+ years of experience.
  • Skills and Experience:
    • Strong expertise in analytical techniques and method development, including High-Performance Liquid Chromatography (HPLC), Dissolution, Liquid Chromatography-Mass Spectrometry (LC-MS), Nuclear Magnetic Resonance (NMR) spectroscopy, and other relevant methods.
    • Experience in the characterization of small molecule compounds, including polymorphism screens, salt and cocrystal screens, physicochemical properties, and stability studies.
    • Knowledge of regulatory guidelines and requirements for analytical method validation and quality control.
    • Demonstrated experience in leading projects and working collaboratively in a multidisciplinary team environment.
    • Strong problem-solving skills, attention to detail, and the ability to work independently.
    • Excellent written and verbal communication skills, with the ability to present complex data clearly and concisely.
  • Preferred Qualifications:
    • Experience in oncology drug development.
    • Knowledge of solid-state chemistry and material science.
    • Familiarity with GMP and GLP regulations.
    • Experience with Chemistry, Manufacturing, and Controls (CMC) aspects of drug development.
About OnKure, Inc.

OnKure, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines that target biologically validated drivers of cancers that are underserved by available therapies. Using a structure- and computational chemistry-driven drug design platform, OnKure is committed to improving clinical outcomes for patients by building a robust pipeline of small molecule drugs designed to selectively target specific mutations thought to be key drivers of cancer.

We offer a generous compensation and benefits package that includes competitive pay, performance-based bonus opportunities, stock options, insurance coverage (health, dental, life, and disability) for full-time employees, self-managed paid time off, and a 401(k) plan with company match. Candidates who live in or are willing to relocate to the Boulder, CO area are preferred.

The expected annual compensation range for this role, based on experience, is $130,000-145,000.