Head of Aseptic Process Simulation & Contamination Control

Jubilant Pharma, LLC; Spokane (WA); On-site; USD 130,000 - 208,000; Full time

Benefits offered by this job

Benefits start day one

FSA/HSA

Life & AD&A Insurance

Disability insurance

Employee Assistance Program (EAP)

Job summary

Jubilant HollisterStier Spokane is hiring an Associate Director to lead the Aseptic Process Simulation (APS) and Contamination Control Strategy (CCS) programs. This role drives best-in-class performance, regulatory readiness, and cross-functional collaboration across a multi-product CDMO.

The ideal candidate brings 10+ years in sterile manufacturing, deep CCS/APS expertise, and a track record with FDA/EMA inspections, while guiding a team to maintain sterility and product quality.

Qualifications

• Bachelor’s degree or higher in a life science or engineering field.
• 10+ years in sterile/aseptic pharmaceutical manufacturing in a cGMP environment.
• Expertise in contamination control, aseptic processing, and media fill/APS programs.
• Experience supporting regulatory inspections (FDA/EMA) and client audits.

Responsibilities

• Own and govern JHS APS and CCS programs.
• Set and govern internal standards for APS and CCS.
• Continuously optimize programs to be best in class for multi-product CDMO.
• Oversee governance for site APS and CCS programs.
• Support client and regulatory audits.
• Maintain NAI or VAI stance for site regarding APS/CCS.
• Represent JHS as SME on CCS/APS.
• Partner with cross-functional site leaders.
• Provide cross-functional technical leadership in CCS/APS.
• Report performance metrics to team and site leadership.
• Manage resources dedicated to CCS/APS; delegate tasks to TS resources.
• Ensure timely completion of all TS tasks for CCS/APS.
• Support investigations and impact assessments for deviations.

Skills

Leadership

Contamination control

Aseptic processing

Regulatory inspections

Quality risk management

Media fill / APS

Environmental monitoring

cGMP compliance

Project management

Team management

Education

Bachelor’s degree in Life Sciences

Job description

Jubilant HollisterStier Spokane is hiring an Associate Director to lead the Aseptic Process Simulation (APS) and Contamination Control Strategy (CCS) programs. This role drives best-in-class performance, regulatory readiness, and cross-functional collaboration across a multi-product CDMO.

The ideal candidate brings 10+ years in sterile manufacturing, deep CCS/APS expertise, and a track record with FDA/EMA inspections, while guiding a team to maintain sterility and product quality.