Associate Director, Analytical Development

Mirum Pharmaceuticals, Inc.; Foster City (CA); On-site; USD 190,000 - 210,000; Full time

Job summary

Mirum Pharmaceuticals, Inc. in Foster City is seeking an Associate Director of Analytical Development – Biologics to join our team and drive method development, validation, technology transfer, and lifecycle management for biologics in a GMP environment.

You will lead cross-functional CMC teams and oversee method transfers to multiple sites, review validation reports, and ensure robust analytical testing. A strong hands-on scientist with 8+ years of biologics experience is required.

Qualifications

• 8+ years of biologics pharma manufacturing/testing experience.
• Experience with analytical instruments used for biologics.
• Knowledge of GXP and regulatory requirements.

Responsibilities

• Serve on cross-functional CMC teams with QA, QC, Manufacturing, and Regulatory.
• Lead and support method transfer between external labs.
• Review analytical method validation and transfer docs.
• Provide technical support to receiving labs on procedures and instrumentation.
• Ensure transferred methods meet acceptance criteria for GMP testing.
• Support risk and gap assessments and method comparability for transfers.
• Oversee reagent qualification and inventory management.
• Record and report analytical results in LIMS and other systems.
• Collaborate with QC/QA on investigations of OOS/OOT/OOE deviations.

Skills

Interpersonal collaboration

Adapt to changing priorities

Technology transfer experience

Analytical troubleshooting

Project management

Detail-oriented

Data management

Regulatory documentation writing

Education

BS/MS in Biochemistry, Chemistry, or Biological Science

Tools

CE

HPLC

UV

LC-MS

Job description

Associate Director, Analytical Development

Foster City

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Mirum Pharmaceuticals’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.