Associate Director, Drug Substance Manufacturing
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 need for liver transplant.
We are looking for an associate director of drug substance manufacturing who is upbeat, organized, self-motivated, collaborative and detail oriented. The role requires being able to strategically prioritize activities 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 and will report into the vice president of CMC & project management.
- Lead the drug substance development and manufacturing function within a small dynamic team for multiple late stage programs
- Manage the supply chain for drug substance supporting clinical trials through commercialization
- Oversee process optimization, manufacturing and validation activities
- Review production documentation and reports
- Author regulatory submission documents
- Bachelor’s degree or higher. PhD in organic chemistry is preferred
- At least 10 years’ work experience in the pharmaceutical/biotech industry with at least 5 years in drug substance manufacturing
- Strong knowledge of US and European cGMP guidelines and requirements
- Strong written and verbal communication skills
- Experience in a fast-paced entrepreneurial environment
KNOWLEDGE, SKILLS, AND ABILITIES:
- Strong interpersonal and problem solving skills.
- Experience negotiating supply agreements
- Late stage development and validation experience
- Proficiency in technical German desirable
- 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
COMPENSATION AND CLASSIFICATION:
- Classification: Full-time position.
- Compensation: Competitive and commensurate with experience; includes equity package.
- Benefits: Medical, dental, and vision, and more.
Please submit your resume to email@example.com