Associate Director, Analytical Development
About The Position
Mirum Pharmaceuticals is seeking an organized, self-motivated, collaborative, detail-oriented Associate Director of Analytical Development – Biologics with a strong analytical background. The role partners with the Executive Director of Analytical Development/QC – Biologics to execute and support method development and validation, technology transfer, and method lifecycle management. The successful candidate will ensure methods are scientifically sound, robust, fit for purpose, and compliant with applicable regulatory requirements. This is a hands-on scientist role that calls for sound scientific judgment and proactive resolution of technical challenges to meet program milestones. The position is located in Foster City.
Requirements
- BS or MS in Biochemistry, Chemistry, or a Biological Science.
- 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.
- 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 and validation.
- Strong attention to detail and accuracy.
- Excellent analytical and data management skills.
- Good documentation and report-writing skills.
- Excellent written and verbal communication skills, including presentations.
- Track record in authoring and reviewing regulatory documentation such as INDs, IMPDs, MAAs, and BLAs.
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 to ensure successful transfers.
- 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.
- Work with QC and QA to support investigations related to OOS, OOT, and OOE results, deviations, and laboratory incidents.
- Follow company SOPs, pharmacopoeia methods, and regulatory guidelines, including USP, EP, ICH, and FDA/EMA requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Director
