Job Information
OnKure, Inc. Director, Analytical Chemistry in Boulder, Colorado
Position Summary: We are seeking a highly motivated and experienced Director of Analytical Chemistry (Drug Substance and Drug Product) to join our PharmSci team. The successful candidate will play a critical role in the development, characterization, and progression of small molecule oncology therapeutics. This individual will be responsible for shaping the analytical strategy, guiding CMC development, and ensuring compliance with global regulatory requirements throughout the drug development lifecycle. The role spans from preclinical to clinical stages and requires close collaboration with cross-functional teams, including Medicinal Chemistry, DMPK, Clinical Operations, and Pharmacology/Biology, to advance our oncology pipeline. In addition to driving method development and validation, this position will oversee external partnerships, ensuring that Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) meet the company’s scientific and operational standards. This role demands leadership in troubleshooting complex analytical challenges, contributing to regulatory submissions, and ensuring that the analytical work adheres to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). This is a highly visible and strategic role within the organization, requiring both scientific expertise and strong project management capabilities. The position will start as an individual contributor and transition to have supervisory responsibilities as the company grows. The position is primarily office-based, with some on-site responsibilities and occasional travel to support collaborations, audits, and regulatory meetings. Essential Duties and Responsibilities: Lead analytical CMC strategy Develop and execute the analytical CMC strategy for drug substance (DS) and drug product (DP) across preclinical and clinical stage assets Project planning – Defining short and long term goals, setting priorities, and establishing and maintaining timeliness and budgets Oversee the development and validation of robust and phase appropriate analytical methods to characterize drug substances and drug products, including but not limited to 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 manage GLP and GMP stability studies to justify material use periods and expiration Stay current with global regulatory changes related to analytical chemistry and guide the team to ensure compliance External Collaboration and Vendor Management: Identify and select appropriate external laboratories and vendors for experimental work Ensure DP and DS compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in all analytical activities 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 Provide technical guidance on complex analytical challenges, such as method failures, unexpected results, or stability issues Proactively address problems that may arise during method development, validation, or routine testing, ensuring that solutions are scientifically sound and regulatory-compliant Manage the transfer of analytical methods from internal labs to external contract research organizations (CROs) and contract manufacturing organizations (CMOs) Contribute to regulatory CMC strategy and the preparation of global regulatory submissions using clear and accurate source documentation Stay updated on regulatory requirements and guidelines to ensure that all analytical work meets current standards Contributions include but are not limited to DP and DS control strategies, justification of specifications 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: Education and Experience: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field with 10+ years of relevant experience in the pharmaceutical or biotechnology industry OR M.S. with 12+ years of experience OR B.S. with 15+ years of experience Technical Expertise: Strong expertise in analytical techniques and method development, including HPLC, dissolution, LC-MS, NMR, spectroscopy, and other relevant methodologies In-depth knowledge of regulatory guidelines and requirements for analytical method validation, quality control, and CMC processes Leadership and Communication: Demonstrated experience in leading projects and collaborating within multidisciplinary teams Strong problem-solving abilities, attention to detail, and the capacity to work independently Excellent written and verbal communication skills, with the ability to present complex data clearly and concisely Regulatory Knowledge: Familiarity with GMP and GLP regulations and experience with CMC aspects of drug development Preferred Qualifications: Small molecule late-stage analytical development Demonstrated success in overseeing regulatory submissions (e.g., IND, NDA) and responding to health authority queries Experience with process development and analytical method lifecycle management, from development through commercialization Experience with regulatory guidelines outside of US (e.g. EMA, JP, MFDS, etc.) Strong understanding of impurity profiling, degradation studies, and forced degradation protocols Proven ability to manage collaborations with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) Experience leading technical teams through challenging analytical issues in a fast-paced, clinical-stage environment Background in utilizing risk-based approaches to define analytical control strategies 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 $200,000-$225,000. 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.