Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our lead program is focused on two severe liver diseases in children, Alagille syndrome and progressive familial intrahepatic cholestasis (PFIC). Both conditions can result in severe itching, liver damage and a need for liver transplant. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
This individual will lead the drug product development and manufacturing function within a completely outsourced environment. The ideal candidate is a self-starter with the ability to work independently under minimal supervision, and who is seeking to be part of an innovative and fast-paced team.
- Lead mid- to late-stage development, validation, and commercial manufacturing activities for drug product and packaging for multiple programs in a 100% out-sourced environment.
- Manage development of novel formulations and post-marketing changes.
- Author, review and approve Module 3 sections of CTD and act as drug product Subject Matter Expert for global regulatory interactions.
- 15+ years in small-molecule drug product development and manufacturing.
- Expertise in development of novel formulations, technology transfer, process optimization and validation.
- Track record of success in leading small-molecule drug product programs in a 100% outsourced small-team environment.
- Thorough knowledge of the drug development process and ICH requirements for NDA and MAA registration.
KNOWLEDGE, SKILLS, AND ABILITIES
- Strong collaboration, leadership, and communication skills.
- Must be able to work in a fast-paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation. Can prioritize and quickly re-prioritize as needed.
- Strong collaborative vendor/supplier management skills.
- Competency in developing, implementing, and delivering aggressive CMC project plans.
- Proactive, pragmatic, team player who demonstrates flexibility, possesses a “can do” attitude and can come up with creative solutions when faced with novel program challenges while showing good judgement, anticipating future consequences, and able to act decisively in the face of ambiguity.
- Has integrity, honesty, conscientiousness, and is team-oriented.