---
title: 'Associate Director, Analytical Development - Biologics at Mirum Pharmaceuticals'
canonical: 'https://feeny.ai/job/associate-director-analytical-development-biologics-mirum-pharmaceuticals-9zjavtcbpqqe'
type: 'job'
last_seen: '2026-11-11'
---

# Associate Director, Analytical Development - Biologics at Mirum Pharmaceuticals

- **Company:** Mirum Pharmaceuticals
- **Location:** Foster City, CA
- **Posted:** 2026-11-06
- **Last confirmed live:** 2026-11-11
- **Apply:** https://job-boards.greenhouse.io/mirumpharmaceuticals/jobs/5286757007

## Job description

## 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.

## About Mirum Pharmaceuticals

## Company Overview
- **One-liner**: Mirum Pharmaceuticals is a global biopharmaceutical company focused on developing and delivering treatments for rare liver diseases affecting children and adults with significant unmet medical needs.
- **Entity Type**: Public (NASDAQ: MIRM)
- **Headquarters**: Foster City, California, USA
- **Founded**: 2018
- **Founders**: Not publicly listed as individual founders; the company was established by a leadership team with deep rare disease and biotech experience who identified a deprioritized therapy for Alagille syndrome and moved decisively to advance it.

## Core Business
- **Primary industry/industries**: Biotechnology / Rare Disease Pharmaceuticals
- **Target customers**: Healthcare providers, patients, and families affected by rare liver diseases (Alagille syndrome, Progressive Familial Intrahepatic Cholestasis, and other cholestatic conditions); B2B relationships with payers, distributors, and healthcare systems globally.
- **Mission or purpose statement**: "Relentlessly Rare" — focused on conditions where the burden is profound and the need is greatest, combining deep expertise with disciplined execution to advance meaningful medicines for people around the world.

## Products & Services
- **LIVMARLI® (maralixibat)**: An oral, once-daily ileal bile acid transporter (IBAT) inhibitor approved for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). Approved in multiple regions including the US and Europe. Additional development programs are underway.
- **Pipeline Programs**: A broad pipeline of investigational medicines targeting significant unmet needs in rare liver diseases, including additional indications for LIVMARLI and other early-stage programs.

## Market Standing
- **Valuation/Market Cap**: As of mid-2025, Mirum’s market capitalization is approximately $1.5–$2.0 billion (fluctuating with stock price; check current data on [ir.mirumpharma.com](https://ir.mirumpharma.com/overview/default.aspx)).
- **Key Metric**: Annual Revenue — Mirum generates revenue from commercial sales of LIVMARLI. In 2024, the company reported total revenue of approximately $290 million (preliminary figure; verify in latest 10-K). The company has transitioned from a development-stage to a commercial-stage biotech.
- **Notable Investors/Partners**: Public institutional investors; key partners include clinical sites, patient advocacy groups (e.g., Alagille Syndrome Alliance, PFIC Network), and global distribution partners for international markets.
- **Growth Signals**: Three approved medicines in its portfolio; global footprint with offices in North America and Europe; expanding pipeline with additional clinical programs; consistent revenue growth from LIVMARLI; growing commercial presence in Europe and other regions.

## Competitive Advantages
- **First-in-class / Best-in-class therapy**: LIVMARLI is the first and only approved treatment for cholestatic pruritus in Alagille syndrome, addressing a critical unmet need with no prior approved therapies.
- **Deep rare disease expertise**: The leadership team has extensive experience in rare disease drug development, regulatory strategy, and commercialization, allowing the company to navigate complex pathways efficiently.
- **Patient-centric culture**: Mirum embeds patient and family voices directly into development and commercial strategy, ensuring therapies meet real-world needs.
- **Disciplined execution**: The company was founded with a single deprioritized asset and rapidly advanced it to approval, demonstrating agility and focus.

## Strategic Focus
- **Expand global access**: Continuing to secure regulatory approvals and market access for LIVMARLI and other pipeline assets across North America, Europe, and other regions.
- **Advance pipeline**: Pursuing additional indications for LIVMARLI and developing new therapies for other rare liver diseases with high unmet need.
- **Deepen patient engagement**: Strengthening relationships with patient communities and advocacy groups to inform research, development, and commercialization.
- **Build commercial infrastructure**: Expanding commercial, medical affairs, and patient services teams globally to support growing product portfolio.

## Why Work Here
- **Mission-driven culture**: Mirum’s core values — "Care, Be Real, Get It Done, and Have Fun, Seriously" — foster a collaborative, high-performance environment where employees are empowered to bring their authentic selves to work.
- **Flexible work environment**: The company supports flexible ways of working, with offices in Foster City (global HQ), Basel (Switzerland), and Zug (Switzerland), plus US Remote roles available for certain positions. Arrangements vary by role.
- **Comprehensive benefits**: 100% employee medical premium coverage (with 100% dependent medical contributions), 4% 401(k) match with immediate vesting, 15% Employee Stock Purchase Plan, four weeks of PTO starting day one, company holidays including a winter shutdown, paid parental leave, up to $5,000 annual tuition reimbursement, and an Employee Assistance Program.
- **Collaborative community**: Regular "Coffee and Chats" and bi-weekly "Lunch Connections" foster cross-functional dialogue. Office environments are designed for connection with stocked snacks, beverages, and (in some locations) catered lunches and on-site baristas.
- **Growth opportunity**: As a high-growth public company with approved products and an expanding pipeline, employees have significant opportunities to contribute to meaningful milestones and career development.

## Sources
1. [mirumpharma.com](https://mirumpharma.com/)
2. [mirumpharma.com/about-us/our-story/](https://mirumpharma.com/about-us/our-story/)
3. [mirumpharma.com/jobs/](https://mirumpharma.com/jobs/)
4. [ir.mirumpharma.com](https://ir.mirumpharma.com/overview/default.aspx)
5. [job-boards.greenhouse.io/mirumpharmaceuticals](https://job-boards.greenhouse.io/mirumpharmaceuticals)

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