Job Description
Position Summary: We are seeking a highly motivated and experienced Senior Scientist in drug product and drug substance Analytical Chemistry and Material Science to join our PharmSci team. The successful candidate will play a key role in the development and characterization of small molecule oncology therapeutics. This role spans the preclinical through clinical space and involves working closely with cross-functional teams, including medicinal chemistry, DMPK, clinical operations, and pharmacology / biology, to support the advancement of our pipeline. This role is primarily office based; however, some laboratory work and travel are expected.
Essential Duties and Responsibilities: - Material Science:
- Design and conduct experiments to characterize the physical and chemical properties of drug candidates, polymorphism, solubility, and stability studies at CDMOs
- Work with the formulation group to advance and nominate a solid form of the drug substance to be advanced to the clinic (e.g. salts, cocrystal, amorphous formulations, etc.)
- 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 (e.g., ICH, FDA, EMA)
- Propose and justify specifications for drug substance and drug product
- Design and monitor GLP and 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 INDs (Investigational New Drug applications) and NDAs (New Drug Applications)
- 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
Qualifications: - 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
- Strong expertise in analytical techniques and method development, including HPLC, Dissolution, LC-MS, NMR, spectroscopy, and other relevant methods
- Experience in the characterization of small molecule compounds, including polymorphism screens, salt and cocrystal screens, physiochemical 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 CMC (Chemistry, Manufacturing, and Controls) aspects of drug development
About OnKure:
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.
To attract the very best talent, OnKure offers 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 $145,000-$165,000.
OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, protected veteran status, disability, or any other protected factors.
Job Tags
Full time, Relocation,