Senior Manager, GxP Analytical Services

BioMarin Pharmaceutical Inc.; San Rafael (CA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

BioMarin Pharmaceutical in San Rafael, CA, seeks a Senior Manager for Analytical Services to lead analytical strategy across commercial and development programs. You will ensure cGMP compliance, manage method transfers and validations, and guide a high-performing team of scientists and associates.

The role requires deep scientific expertise, cross-functional collaboration with QC, Manufacturing, and Regulatory Affairs, and a track record of delivering compliant data and timely project outcomes.

Qualifications

• Bachelor's degree with typically 8+ years of relevant pharmaceutical or biotechnology industry experience, or Master’s with 6+ years.
• Experience leading projects, technical teams, or laboratory workstreams.
• Strong understanding of analytical method validation, transfer, and lifecycle management.

Responsabilités

• Provide technical oversight for analytical method transfers, validation, qualification, verification, troubleshooting, and remediation.
• Lead a team of scientists and research associates in GxP Analytical Services.
• Ensure GMP compliance, inspection readiness, and regulatory support across product lifecycle.

Connaissances

People leadership

Analytical leadership

GxP knowledge

Regulatory understanding

Cross-functional collaboration

Project management

Technical writing

Formation

Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences

Master's degree in related field

Description du poste

BioMarin Pharmaceutical in San Rafael, CA, seeks a Senior Manager for Analytical Services to lead analytical strategy across commercial and development programs. You will ensure cGMP compliance, manage method transfers and validations, and guide a high-performing team of scientists and associates.

The role requires deep scientific expertise, cross-functional collaboration with QC, Manufacturing, and Regulatory Affairs, and a track record of delivering compliant data and timely project outcomes.