Associate Director: Contamination Control & APS

Jubilant Pharma, LLC; Spokane (WA); Presencial; USD 130.000 - 191.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical/Dental/Vision coverage

FSA/HSA availability

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Resumo da vaga

Jubilant HollisterStier LLC in Spokane, WA, seeks an Associate Director to own the Aseptic Process Simulation and Contamination Control Strategy programs, driving state-of-the-art contamination control, regulatory readiness, and site SME leadership for CCS/APS in a sterile manufacturing environment.

The role requires a strong track record in sterile manufacturing, leadership experience, and deep knowledge of Annex 1, FDA/EMA inspections, and technology transfer.

Qualificações

• Bachelor’s degree in a life science or engineering field.
• 10+ years in sterile/aseptic pharma manufacturing within a cGMP environment.
• Expertise in contamination control, aseptic processing, and APS programs.
• Proven track record supporting regulatory inspections (FDA/EMA) and audits.
• Several years in a leadership role.

Responsabilidades

• Own and govern APS and CCS programs.
• Set internal standards for APS and CCS and drive continuous improvement.
• Oversee governance for site APS and CCS programs.
• Support client and regulatory audits.
• Maintain regulatory stance for APS/CCS and report performance metrics.
• Lead cross-functional collaboration and resource planning.

Conhecimentos

Leadership

Regulatory inspections

Quality risk mgmt

Aseptic processing

Environmental monitoring

cGMP compliance

Technology transfer

Formação

Bachelor’s degree in life sciences or engineering

Advanced degree (MS/PhD)

Descrição da vaga

Jubilant HollisterStier LLC in Spokane, WA, seeks an Associate Director to own the Aseptic Process Simulation and Contamination Control Strategy programs, driving state-of-the-art contamination control, regulatory readiness, and site SME leadership for CCS/APS in a sterile manufacturing environment.

The role requires a strong track record in sterile manufacturing, leadership experience, and deep knowledge of Annex 1, FDA/EMA inspections, and technology transfer.