Sr. Manager/Assoc. Director, Analytical Development

Mirum Pharmaceuticals in Santa Clarita, CA

  • Industry: Executive Management - Engineering/Production
  • Type: Full Time
position filled

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.
Position Summary:

Help to drive and support all of the CMC efforts including QC, analytical methods development, method validation, method transfer, reference standard and stability management. 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.
Job Duties:
  • Oversee and manage 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 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 method, 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.
  • Ph.D. or Master's degree in 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 late phase to commercial development (both drug substance and drug product).
Knowledge, Skills & 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.
Work Environment:
  • This is a high growth, fast paced small organization. The ability to be productive and successful in this type of a work environment is critical.
  • Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10 % of work time.

Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

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