Open

Positions

Director, Drug Substance

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.

 

POSITION SUMMARY

We are looking for a 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 pharmaceutical company. This position is located in Foster City.

 

JOB FUNCTIONS / RESPONSIBILITIES

  • 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 and commercial 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.

 

QUALIFICATIONS

Education / Experience:

  • Bachelor’s degree or higher. PhD in organic chemistry is preferred.
  • At least 12+ years of work experience in the pharmaceutical/biotech industry with at least 6 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.

 

To apply, please send your resume to careers@mirumpharma.com.

Open

Positions

Associate 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.

 

POSITION SUMMARY

The Associate Director of Analytical Development will be responsible for managing analytical activities at external organizations in support of drug substance and drug product development. This position requires experience with the oversite of external testing, clinical-stage product development, and method development/validation/transfer.

 

JOB FUNCTIONS / RESPONSIBILITIES

  • Oversee and manage DS and DP CRO/CMO vendors engaged in AD and QC activities.
  • Provide technical review of analytical data integrity, method development, and method validation protocols/reports.
  • Act as primary liaison for analytical testing performed by external contract organizations and review QC test results.
  • Manage the transfer of analytical methods for development-stage candidates for analysis of excipients, drug substance, and drug product formulations to CMOs.
  • Ensure that testing methodologies meet phase-appropriate cGMP requirements.
  • Work with internal subject matter experts to write and review analytical test methods, protocols, and development reports.
  • Review method qualification/validation plans and reports by external vendors.
  • Author analytical CMC modules to support regulatory filings.
  • Develop sensitive and robust analytical test methods to support release testing and characterization of our drug products.

 

QUALIFICATIONS

Education / Experience:

  • Ph.D. or Master’s degree in organic chemistry, analytical chemistry or related discipline with 7-10+ years’ experience in an analytical laboratory.
  • Solid background and experience in analytical method development.
  • Prior experience in early phase and late phase development (both drug substance and drug product).

Knowledge, Skills and Abilities:

  • In-practice knowledge of USP, EP, ICH and FDA guidelines.
  • Familiar with the operation in a GMP environment.
  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
  • Proven strong interpersonal, organization and problem-solving skills.

 

To apply, please send your resume to careers@mirumpharma.com.