Senior Director/Executive 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.
Provide strategic, managerial, and technical leadership to a small team of internal analytical scientists in a fully out-sourced environment as well as provide scientific input to scientists from CMOs and CTLs as needed.
- Establish strategic plans and provide leadership to ensure priorities are met in a fast-paced environment.
- Proactively identify analytical gaps and deficiencies and initiate mitigation strategies across programs.
- Apply technical and management expertise to meet project goals and timelines, and to make technical and management decisions to keep projects on track.
- Select, oversee, and continuously assess CMOs/CTLs. Manage and oversee review of raw data packages associated with method qualifications/validations, release testing, stability testing, and other characterization testing of drug substances and drug products.
- Support relevant vendors (CMOs/CTLs) during the development and characterization of the drug substance and drug product. Travel to CMOs and CTLs as needed.
- Ensure the timely preparation, review, and approval of technical reports, monographs, appropriate sections of regulatory drug submissions, etc.
- Work closely with Manufacturing, Regulatory, and Quality groups to support technology transfers and regulatory submissions with appropriate documentation.
- Ensure the development of quality processes that comply with ICH guidelines; work with QA to assure high quality is maintained and a strong quality system is developed around the drug substance and product.
- Work within budget and provide functional input into yearly budgets and long-range plans.
- Ph.D. in Chemistry, Pharmaceutical Sciences, or Pharmaceutics or relevant industrial experience in CMC with a major pharmaceutical or generic pharmaceutical company.
- Knowledgeable in analytical techniques such as HPLC, GC, FTIR, UV-Vis, KF, and other USP and EP methods with hands on experience and expertise with analytical techniques and troubleshooting instrumentation.
- Working knowledge of phase-appropriate cGMP requirements, ICH, FDA, USP, EP and other pharmaceutical industry regulatory guidelines.
- Meticulousness with details while able to see “big picture”. Proven ability to multi-task, be flexible, make decisions, and handle multiple projects simultaneously.
- Previous active participation in contributing to company Quality Systems and writing and reviewing of departmental SOPs.
- Sound understanding of CMC regulatory requirements and direct experience with compiling CMC sections for INDs, NDAs, and MAAs and responding to regulatory queries.
- Experience with regulatory interactions and inspections.
- Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.
- Strong ability to communicate effectively with team members creating an environment that fosters successful teamwork, collaboration, and cooperation.
- Experience in a small company environment strongly preferred. Ability to work in a fast-paced virtual environment with demonstrated ability to juggle multiple competing tasks and demands while maintaining positive attitude.
To apply, please send your resume to firstname.lastname@example.org.