Associate Director, Process Chemistry & CMC
- Job Title
- Associate Director, Process Chemistry & CMC
- Job ID
- Boulder, CO
- Other Location
OnKure has an immediate opening for an experienced process chemist to help build and lead our Process Chemistry and CMC functions.
What You Will Achieve:
You will primarily be responsible for optimizing the API manufacturing process for OnKure’s lead program, OKI-179. Ideally, you will work in the lab while managing CDMO research, development, and manufacturing activities. You will also be responsible for process optimization, analytical method optimization, if necessary; process validation, and all API regulatory submission documents.
How You Will Achieve It:
- As appropriate, lead and perform activities in synthetic organic chemistry, process chemistry, and analytical chemistry
- Act in a leadership role for our Research team
- Technology transfer
- CDMO management
- Technical writing
- ICH Guidance expectations
- CMC regulatory documentation requirements
- Educational background in chemistry
- Extensive experience in the laboratory solving challenging problems
- Experience managing performance of internal and external resources
- Experience leading programs from research through validation
- Experience working with Quality Assurance and thorough knowledge of ICH guidance documents
- Experience authoring CMC reports and regulatory documents
OnKure, Inc. is a private biotech company, based in Boulder, Colorado. The company was founded and is led by several scientific leaders from Array BioPharma, another Boulder-based company. Our mission is to create novel, high quality drugs to provide meaningful therapy for cancer patients. Our near-term goals are to advance our clinical stage drug, OKI-179, into several Phase 2 clinical trials, build a state-of-the-art drug discovery group and establish a robust pipeline of projects and development candidates.
Our Boulder facilities feature modern offices, and new laboratories are under construction. With the mountains at our doorstep, great schools, cultural and unparalleled outdoor activities, Boulder is the No. 1 place to live out of the 150 most populous metro areas in the U.S. for the second year in a row!
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), self-managed paid time off, and a 401(k) plan with company match. We operate on a flexible schedule that allows a combination of both in-office and home-based work.
Annual compensation range for this role, based on experience is $135,000 - $215,000.
OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected factors.