Associate Director, Process Validation & Risk

Vaxcyte, Inc; San Carlos (CA); On-site; USD 174,000 - 203,000; Full time

Benefits offered by this job

Comprehensive benefits

Equity component

Job summary

Vaxcyte, Inc is looking for an Associate Director, Process Validation and Risk Management to lead the validation of manufacturing processes. This position will require collaboration across various departments to ensure compliance with regulatory standards and successful commercialization.

The ideal candidate will have a minimum of 9 years of experience in biologics manufacturing, showcasing leadership and innovation in process validation. This role offers a competitive salary range of $174,000 – $203,000, with benefits.

Qualifications

• 9+ years for Ph.D., 11+ years for M.S./M.A., 14+ years for B.S./B.A.
• Strong experience in biologics/vaccine manufacturing.
• Excellent communication and stakeholder engagement skills.

Responsibilities

• Provide strategic and scientific leadership for process validation.
• Support lifecycle management and continuous process verification.
• Contribute to regulatory filings and compliance activities.

Skills

Process validation (PPQ/CPV)

Technology transfer and commercialization

Quality risk management (ICH Q9)

Leadership in matrixed environments

Problem-solving skills

Education

Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline

Job description

Vaxcyte, Inc is looking for an Associate Director, Process Validation and Risk Management to lead the validation of manufacturing processes. This position will require collaboration across various departments to ensure compliance with regulatory standards and successful commercialization.

The ideal candidate will have a minimum of 9 years of experience in biologics manufacturing, showcasing leadership and innovation in process validation. This role offers a competitive salary range of $174,000 – $203,000, with benefits.