Senior Manager, GxP Analytical Services Lab

BioMarin Pharmaceutical Inc.; San Rafael (CA); Hybrid; USD 124,000 - 171,000; Full time

Benefits offered by this job

Medical, dental, vision, and life保险

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Job summary

BioMarin Pharmaceutical Inc. is seeking a Senior Manager for Analytical Services GxP Laboratory to lead analytical operations across commercial products and late-stage development.

You will manage method transfers, validation, verification, and investigations in a cGMP environment while partnering with QA, Regulatory Affairs, and Manufacturing to ensure compliant, timely data for product lifecycle management.

Qualifications

• Bachelor’s degree in a pharmaceutical/biotech-related field with 8+ years in pharma/biotech analytical operations.
• Master’s degree with 10+ years of relevant industry experience and leadership.
• Strong understanding of analytical method validation, transfer, troubleshooting, and lifecycle management.

Responsibilities

• Provide technical leadership for analytical method transfers, validation, and remediation activities.
• Review and approve complex documents, protocols, and regulatory submissions.
• Lead a high-performing team ensuring quality, compliance, and inspection readiness.

Skills

Analytical method validation

Leadership

GxP compliance

Regulatory inspections

Data integrity

Technical writing

Education

Bachelor’s degree in Chemistry/Biochemistry/Biology or related field

Master’s degree with 6+ years of relevant experience

Tools

GxP laboratories

Job description

BioMarin Pharmaceutical Inc. is seeking a Senior Manager for Analytical Services GxP Laboratory to lead analytical operations across commercial products and late-stage development.

You will manage method transfers, validation, verification, and investigations in a cGMP environment while partnering with QA, Regulatory Affairs, and Manufacturing to ensure compliant, timely data for product lifecycle management.