Associate Director, Aseptic Process & Contamination Control

Jubilant Pharma Limited; Spokane (WA); Presencial; USD 78.000 - 208.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Dental Insurance

Vision Insurance

FSA/HSA

Life & AD&D Insurance

Disability Insurance

Descripción de la vacante

Jubilant HollisterStier LLC in Spokane, WA, is hiring a senior leader for APS/CCS programs in a sterile manufacturing environment. You will oversee standards, optimize multi-product CMO programs, and partner with cross-functional site leaders to drive quality and regulatory readiness.

The role requires 10+ years in aseptic pharma, strong regulatory experience, and leadership capabilities. Compensation starts at $130,275 and goes up to $208,400 plus benefits, with day-one coverage and growth

Formación

• Bachelor’s degree in a life science or engineering discipline.
• 10+ years in sterile / aseptic pharmaceutical manufacturing within a cGMP environment.
• Expertise in contamination control, aseptic processing, and media fill / APS programs.
• Proven track record supporting and presenting during regulatory inspections (FDA, EMA) and customer audits.
• Leadership or people-management experience.
• Mastery in Contamination Control Strategy and quality risk management (Annex 1).
• Mastery in Aseptic processing and APS / media fill design (PDA TR 22).
• Expert in Environmental and personnel monitoring / microbiology (USP).
• Expert in cGMP and regulatory inspection management (FDA, EMA, 21 CFR 210/211).
• Expert in Process validation, CPV, and technology transfer.
• Expert in Deviation / CAPA, change control, and root cause analysis.
• Expert in Sterile manufacturing technologies (isolator / RABS, fill-finish, lyophilization).

Responsabilidades

• 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 resources dedicated to CCS/APS.
• Delegate tasks associated to CCS/APS to TS resources.
• Ensure all TS tasks associated with CCS/APS are completed on time.
• Support investigations and impact assessments for APS/CCS deviations.
• Other tasks as assigned.

Conocimientos

Sterile / aseptic manufacturing

Contamination control

Regulatory inspections (FDA/EMA)

Leadership / people management

cGMP compliance

Media fill / APS programs

Environmental monitoring

Process validation / CPV

Deviation / CAPA

Technology transfer

Quality risk management (Annex 1)

Isolator / RABS

Fill-finish / Lyophilization

Regulatory audits

Educación

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

Advanced degree (MS or PhD) preferred

Descripción del empleo

Jubilant HollisterStier LLC in Spokane, WA, is hiring a senior leader for APS/CCS programs in a sterile manufacturing environment. You will oversee standards, optimize multi-product CMO programs, and partner with cross-functional site leaders to drive quality and regulatory readiness.

The role requires 10+ years in aseptic pharma, strong regulatory experience, and leadership capabilities. Compensation starts at $130,275 and goes up to $208,400 plus benefits, with day-one coverage and growth