Director, Immunoassay Development — Vaccine Analytics Leader

Vaxcyte, Inc

San Carlos (CA)

On-site

USD 213,000 - 250,000

Full time

3 days ago

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Benefits offered by this job

Equity compensation

Comprehensive benefits

Job summary

Vaxcyte is seeking an accomplished Director, Immunoassay Development to join the CMC Immunoassay group and provide scientific and strategic leadership for immunoassay reagents and reference materials across the vaccine pipeline.

A key focus will be stewardship of the VAX-31 MSD immunoassay platform, with partnership to ensure knowledge transfer and long-term robustness of strategy as responsibilities transition into Analytical Development.

Qualifications

PhD with 10+ years in immunoassay development leadership in vaccine or biologics settings.
Hands-on expertise developing, transferring, validating immunoassays and lifecycle management.
Strong knowledge of GMP, regulatory submissions and analytical method validation.

Responsibilities

Establish and scale the immunoassay capability within CMC Immunoassay group.
Provide daily lab leadership, planning, scheduling, data review, and technical support.
Lead and mentor a lab team responsible for immunoassay development, qualification, transfer and testing.
Oversee outsourced immunoassay activities with CROs/CDMOs and reagents vendors.
Develop phase-appropriate immunoassay strategies across vaccine pipeline and lifecycle.
Represent Immunoassay Development in governance forums and cross-functional reviews.