Biologics Analytical Development Lead

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

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.