Associate Director, Analytical Development
Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.
The Associate Director of Analytical Development will be responsible for managing analytical activities at external organizations in support of drug substance and drug product development. This position requires experience with the oversite of external testing, clinical-stage product development, and method development/validation/transfer.
JOB FUNCTIONS / RESPONSIBILITIES
- Oversee and manage DS and DP CRO/CMO vendors engaged in AD and QC activities.
- Provide technical review of analytical data integrity, method development, and method validation protocols/reports.
- Act as primary liaison for analytical testing performed by external contract organizations and review QC test results.
- Manage the transfer of analytical methods for development-stage candidates for analysis of excipients, drug substance, and drug product formulations to CMOs.
- Ensure that testing methodologies meet phase-appropriate cGMP requirements.
- Work with internal subject matter experts to write and review analytical test methods, protocols, and development reports.
- Review method qualification/validation plans and reports by external vendors.
- Author analytical CMC modules to support regulatory filings.
- Develop sensitive and robust analytical test methods to support release testing and characterization of our drug products.
Education / Experience:
- Ph.D. or Master’s degree in organic chemistry, analytical chemistry or related discipline with 7-10+ years’ experience in an analytical laboratory.
- Solid background and experience in analytical method development.
- Prior experience in early phase and late phase development (both drug substance and drug product).
Knowledge, Skills and Abilities:
- In-practice knowledge of USP, EP, ICH and FDA guidelines.
- Familiar with the operation in a GMP environment.
- Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
- Proven strong interpersonal, organization and problem-solving skills.
To apply, please send your resume to firstname.lastname@example.org.