Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our programs are focused on cholestatic liver diseases 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/Director for drug product development requires extensive experience in manufacturing process development, optimization, and validation. This role will support the product launch by leading the planning and execution of drug product process validation. This role is also required to author and review CMC sections of regulatory filing documents and help draft responses to address questions from regulatory agencies. In addition, this person will help support the formulation and manufacturing process development of new chemical entities.
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 drug product manufacturing process transfer, optimization, and validation activities within a completely outsourced environment.
- Support product launch and regulatory-related activities at pre- & post-approval stages.
- Lead the planning and manufacturing of Commercial drug product.
- Author/review relevant CMC sections to support regulatory filing and address regulatory reviewer comments with data-supported responses.
- Provide on-site presence at CDMOs as needed to achieve objectives.
- Lead drug supply manufacturing and packaging to support clinical studies.
- Support formulation development and optimization for new chemical entities.
- 10+ years in small molecule drug product development and manufacturing.
- Expertise in development of novel formulations, technology transfer, process optimization and validation.
- Track record of 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 make decisions decisively in the face of ambiguity.
- Has integrity, honesty, conscientiousness, and is team-oriented.
To apply, please send your resume to firstname.lastname@example.org.