Associate Director, Process Validation and Risk Management

Essential Functions

• Process Validation Leadership
• Risk Management
• Commercialization & Lifecycle Support
• Cross-functional Interface
• Technical Oversight
• Regulatory
• Process Validation & Comparability
• Raw Material & Network Support
• Communication & Leadership

Requirements

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A.
• Strong experience in biologics/vaccine manufacturing, including:
• Process validation (PPQ/CPV)
• MSAT, technical operations, or late-stage development
• Technology transfer and commercialization
• Experience in quality risk management (ICH Q9) and regulatory expectations
• Demonstrated leadership in matrixed or cross-functional team environments
• Ability to apply deep technical knowledge to develop strategies and drive execution
• Strong problem-solving, organizational, and strategic planning skills
• Excellent communication and stakeholder engagement skills
• Ability to analyze data and align stakeholders with organizational strategy
• Innovative and entrepreneurial mindset to drive continuous improvement
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Reports to

Senior Director, Process Validation

Location

San Carlos, CA or North Carolina

Compensation

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $174,000 – $203,000 (SF Bay Area). Salary ranges for non-California locations may vary.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.