Senior Manager, Analytical Services (GxP)

Xtalks; San Rafael (CA); On-site; USD 190,000 - 260,000; Full time

Job summary

BioMarin is seeking a Manager/Senior Manager of Analytical Services in its GxP laboratory to lead analytical method transfers, validation, verification and investigations across commercial and development programs in a cGMP environment.

You will manage a team of scientists and research associates, drive data-driven decision making, ensure regulatory compliance, inspections readiness, and collaboration with QA, Regulatory Affairs and Manufacturing to support product lifecycle and

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field.
• Master’s degree with typically 6+ years of relevant experience.
• Prior experience leading projects, technical teams, or laboratory workstreams.
• Previous experience leading a high-performing team is preferred.

Responsibilities

• Provide technical oversight for analytical method transfers, validation, qualification, verification, troubleshooting, and remediation activities.
• Lead a team of scientists and research associates in a cGMP environment to deliver high-quality data.
• Ensure compliance with GMP, GDP, EHS, data integrity, and regulatory requirements.
• Partner with QA, Regulatory Affairs, Manufacturing, and external labs to support product lifecycle management.
• Prepare for and participate in regulatory inspections and internal audits.

Skills

Leadership

Regulatory knowledge

Analytical thinking

Project management

Education

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

Master's degree in a related field

Job description

BioMarin is seeking a Manager/Senior Manager of Analytical Services in its GxP laboratory to lead analytical method transfers, validation, verification and investigations across commercial and development programs in a cGMP environment.

You will manage a team of scientists and research associates, drive data-driven decision making, ensure regulatory compliance, inspections readiness, and collaboration with QA, Regulatory Affairs and Manufacturing to support product lifecycle and