Process Validation & Risk Strategy Lead — Equity

Dormont Manufacturing Co; San Carlos (CA); On-site; USD 174,000 - 203,000; Full time

Benefits offered by this job

Comprehensive benefits

Equity component

Competitive compensation

Job summary

Vaxcyte is seeking an Associate Director, Process Validation and Risk Management to lead validation practices across their manufacturing processes. The role includes technical strategy execution, regulatory compliance, and lifecycle management.

The successful candidate will provide leadership and collaborate with internal and external partners to drive successful commercialization. A degree in Chemical/Biochemical Engineering with significant experience in biologics manufacturing is required. Competitive compensation and benefits are offered.

Qualifications

• Minimum of 9+ years for Ph.D. in relevant experience.
• Strong experience in biologics/vaccine manufacturing.
• Ability to develop strategies and drive execution.

Responsibilities

• Lead and facilitate commercial process validation and risk management activities.
• Ensure alignment of validation activities with regulatory expectations.
• Collaborate cross-functionally to support commercialization.

Skills

Biologics/vaccine manufacturing

Process validation (PPQ/CPV)

Quality risk management

Technical operations

Data analysis

Stakeholder engagement

Problem solving

Strategic planning

Education

Ph.D. in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline

M.S./M.A. with 11+ years of experience

B.S./B.A. with 14+ years of experience

Job description

Vaxcyte is seeking an Associate Director, Process Validation and Risk Management to lead validation practices across their manufacturing processes. The role includes technical strategy execution, regulatory compliance, and lifecycle management.

The successful candidate will provide leadership and collaborate with internal and external partners to drive successful commercialization. A degree in Chemical/Biochemical Engineering with significant experience in biologics manufacturing is required. Competitive compensation and benefits are offered.