MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
We are looking for an Associate Director of Analytical Development – Biologics who is organized, self-motivated, collaborative, detail-oriented, has a strong analytical background and knowledge base. The person filling this role will partner with the Executive Director of Analytical Development/QC – Biologics to execute and support method development and validation, technology transfer, method lifecycle management, ensuring that methods are scientifically sound, robust, fit for purpose and compliant with applicable regulatory requirements. This role requires a pragmatic hands-on scientist who exercises scientific judgement and proactively identifies and resolves technical challenges to meet program milestones. This position is located in Foster City.
JOB FUNCTIONS/RESPONSIBILITIES
- Serve as a key member of cross-functional CMC teams comprising Quality, Manufacturing, and Regulatory representatives
- Lead and support method transfer activities between external sending and receiving laboratories
- Review analytical method validation and transfer protocols and reports
- Provide technical support to receiving laboratories on analytical procedures and instrumentation as required and to ensure successful transfer
- Ensure transferred methods meet predefined acceptance criteria and are suitable for routine GMP testing
- Support risk assessments, gap assessments, and method comparability evaluations in support of method transfer
- Support analytical method related and product trending activities
- Oversee reference standard and critical reagent qualification and inventory management
- Record and report analytical results accurately in worksheets, logbooks, LIMS, or electronic systems
- Review analytical data for accuracy, completeness, and compliance with GMP and data integrity requirements
- Record and report analytical results accurately in LIMS, or electronic systems
- Work with QC and QA to support investigations related to OOS, OOT and OOE, deviations and laboratory incidents
- Follow company SOPs, pharmacopoeia methods, and regulatory guidelines, e.g. USP, EP, ICH, and FDA/EMA requirements
QUALIFICATIONS
Education /Experience:
- BS/MS in Biochemistry, Chemistry, or a Biological Science with 8+ years of industry experience in biologics pharmaceutical manufacturing and testing
- Hands-on experience with analytical instruments, especially CE, HPLC, UV, and LC-MS for biological compounds
- Knowledge of GXP
KNOWLEDGE, SKILLS, AND ABILITIES
- Strong interpersonal skills and ability to collaborate across functions
- Ability to respond effectively to changing priorities, evolving program needs, and unexpected technical challenges
- Experience with technology transfer to multiple locations and countries for clinical and late phase product testing
- Ability to investigate and troubleshoot analytical issues
- Ability to work under deadlines and manage multiple projects
- Experience with stability testing and analytical method transfer/validation.
- Strong attention to detail and accuracy
- Excellent analytical skills and data management skills
- Good documentation and report-writing skills.
- Excellent communication skills for both written and verbal presentations
- Track record in authoring and reviewing of regulatory documentation (e.g. INDs, IMPD, MAAs, BLAs)
The salary range for this position is $190,000 to $210,000USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Skills Required
- BS or MS degree in Biochemistry, Chemistry, or Biological Science
- 8+ years of industry experience in biologics pharmaceutical manufacturing and testing
- Hands-on experience with CE, HPLC, UV, and LC-MS analytical instruments for biological compounds
- Knowledge of GxP
- Experience with technology transfer across multiple locations and countries
- Experience with analytical method development, stability testing, transfer, and validation
- Ability to investigate and troubleshoot analytical issues
- Experience authoring and reviewing regulatory documentation, including INDs, IMPDs, MAAs, or BLAs
- Strong interpersonal, collaboration, communication, analytical, data management, documentation, and report-writing skills
- Ability to manage multiple projects, changing priorities, deadlines, and technical challenges
Mirum Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Mirum Pharmaceuticals and has not been reviewed or approved by Mirum Pharmaceuticals.
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Equity Value & Accessibility — Equity grants to new hires and an employee stock purchase plan make ownership more accessible and can boost total rewards when performance is strong. Public disclosures highlight frequent option/RSU inducements.
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Healthcare Strength — Comprehensive medical, dental, and vision coverage is employer-paid for employees, with added life, disability, and EAP support. This combination reduces financial burden and enhances overall wellbeing.
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Leave & Time Off Breadth — A broad time-off program includes multiple paid company holidays, a year-end shutdown, accrued vacation, and paid parental leave. This breadth provides additional rest periods beyond standard vacation.
Mirum Pharmaceuticals Insights
What We Do
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. Mirum’s approved medication is LIVMARLI® (maralixibat) oral solution which is approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older. Mirum’s late-stage pipeline includes two investigational treatments for debilitating liver diseases affecting children and adults. Maralixibat (LIVMARLI), an oral ileal bile acid transporter (IBAT) inhibitor, is currently being evaluated in clinical trials for pediatric liver diseases and includes the MARCH Phase 3 study for progressive familial intrahepatic cholestasis (PFIC) and the EMBARK Phase 2b study for patients with biliary atresia. In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome. Mirum has submitted a Marketing Authorization Application to the European Medicines Agency for maralixibat for the treatment of cholestatic liver disease in patients with Alagille syndrome. Mirum’s second investigational treatment, volixibat, also an oral IBAT inhibitor, is being evaluated in three potentially registrational studies including the OHANA Phase 2b study for pregnant women with intrahepatic cholestasis of pregnancy, VISTAS Phase 2b study for adults with primary sclerosing cholangitis, and the VANTAGE Phase 2b study for primary biliary cholangitis.
