Senior Manager, GxP Analytical Services

BioSpace

San Rafael (CA)

On-site

USD 150,000 - 190,000

Full time

7 days ago

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Job summary

BioMarin is seeking a Manager/Senior Manager for Analytical Services in its GxP laboratory to lead a scientists and research associates, drive method transfers, and oversee validation and regulatory support across commercial and development programs.

The role emphasizes people leadership, technical oversight, and collaboration with QA, Manufacturing, Regulatory Affairs, and external labs to sustain quality and compliance in a fast-paced biotech environment.

Qualifications

Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field with typically 8+ years of pharma/biotech experience; or Master’s with typically 6+ years.
Prior experience leading projects, technical teams, or laboratory workstreams.
Strong knowledge of analytical method validation, transfer, troubleshooting, and lifecycle management.
Demonstrated leadership, project management, and stakeholder management capabilities.
Experience guiding regulatory inspections, audits, and compliance programs.

Responsibilities

Provide technical oversight for analytical method transfers, validation, qualification, verification, troubleshooting, and remediation activities.
Lead a team of scientists and research associates within the GxP Analytical Services organization.
Ensure GMP compliance, inspection readiness, and regulatory support across product lifecycles.
Partner with Manufacturing, Quality Control, Regulatory Affairs, Quality Assurance, and contract labs to meet program objectives.
Drive data-driven decision-making and strategic planning for Analytical Services across commercial and development programs.