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.
We are looking for an Associate Director of API/Drug Substance who is upbeat, organized, self-motivated, collaborative, detail oriented, has a strong technical background and knowledge base. The role requires being able to tactically prioritize to meet both short-term and long-term goals. This is a fantastic opportunity to make an impact, wear many hats, and be a part of an exciting growing biotech company. This position is located in Foster City.
- Support drug substance development and manufacturing function within a small dynamic team for multiple late stage programs.
- Support the tech transfer and production for late-stage supply.
- Manage the supply chain for drug substance supporting clinical trials through commercialization.
- Oversee pre-NDA activities such as, process optimization, manufacturing and validation.
- Review production documentation and reports.
- Author regulatory submission documents to help support an NDA/MAA.
- Bachelor’s degree or higher. PhD in organic chemistry is preferred.
- At least 10 years of work experience in the pharmaceutical/biotech industry with at least 5 years in API/drug substance manufacturing with small molecules.
- Experience with building successful, collaborative relationships with CMOs.
- Strong knowledge of US and European cGMP guidelines and requirements.
- Strong written skills on previous NDAs and MAAs required.
- Able to verbally communicate status updates, issues, and strategic solutions to problems.
- Must have experience in a fast-paced entrepreneurial environment.
- Able to be flexible in a changing environment.
KNOWLEDGE, SKILLS, AND ABILITIES
- Strong interpersonal and problem-solving skills.
- Late stage development and validation experience.
- Meticulousness with details and precision while able to see “big picture”.
- Assertiveness, pro-activity, professionalism, and confidence.
- Ability to multi-task and handle pressure.
- Drive for excellence and self-motivated.
- Willingness to travel and to participate in some teleconferences during non-business hours.