Associate Director, Aseptic Process & Contamination Control

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

Benefits offered by this job

Medical, Dental & Vision

FSA/HSA

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA, seeks an Associate Director for Aseptic Process Simulation (APS) and Contamination Control Strategy (CCS). You will lead, govern, and continuously improve site APS and CCS programs to ensure quality and regulatory compliance across multi-product operations.

You will partner with cross-functional teams, drive strategic leadership in contamination control, and liaison with audits and clients while guiding a skilled staff in a fast-paced, sterile

Qualifications

• Bachelor's degree in a life science or engineering discipline.
• 10+ years in sterile/aseptic pharmaceutical manufacturing within a cGCM environment.
• Expertise in contamination control, aseptic processing, and media fill/APs programs.
• Experience supporting regulatory inspections (FDA/EMA) and customer audits.

Responsibilities

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

Skills

Sterile/aseptic manufacturing

Contamination control

Aseptic processing

Media fill/APS programs

Regulatory inspections (FDA/EMA)

Leadership/people management

Quality risk management (Annex 1)

cGMP regulatory inspection management

Process validation/CPV

Deviation/CAPA/root cause analysis

Sterile technologies (isolator/RABS,填)

Education

Bachelor's degree in Microbiology, Pharmacy, Chemistry, Biology, Chemical or Biomedical Engineering

MS or PhD in a relevant scientific discipline

Job description

Jubilant HollisterStier LLC in Spokane, WA, seeks an Associate Director for Aseptic Process Simulation (APS) and Contamination Control Strategy (CCS). You will lead, govern, and continuously improve site APS and CCS programs to ensure quality and regulatory compliance across multi-product operations.

You will partner with cross-functional teams, drive strategic leadership in contamination control, and liaison with audits and clients while guiding a skilled staff in a fast-paced, sterile