Associate Director, Aseptic Strategy & Contamination Control

ALKU; Spokane (WA); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

ALKU in the United States (Spokane, WA) seeks an Associate Director for Contamination Control Strategy (CCS) & Aseptic Process Simulation (APS) to govern APS/CCS programs and drive site standards. You will provide cross-functional technical leadership, support client and regulatory audits, and safeguard product quality and sterility.

You will lead contamination control and aseptic processing strategies, mentor teams, and ensure continued compliance with cGMP, FDA/EMA expectations, and Annex 1

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 APS programs.
• Experience supporting 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 (USP <1116>).
• 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 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 as compared to industry standards.
• 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 the company as industry SME on CCS/APS.
• Partner with cross-functional site leaders.
• Provide cross-functional technical leadership in the areas of 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.
• Ensure all TS tasks associated with CCS/APS are completed on time.
• Support or delegate resources to support investigation and impact assessment for APS/CCS related deviations.
• Other tasks as assigned.

Conocimientos

Leadership

People management

Regulatory inspections

Cross-functional collaboration

Technical leadership

Educación

Bachelor's degree in Microbiology/Pharmacy/Chemistry/Biology/Engineering

MS or PhD preferred

Descripción del empleo

ALKU in the United States (Spokane, WA) seeks an Associate Director for Contamination Control Strategy (CCS) & Aseptic Process Simulation (APS) to govern APS/CCS programs and drive site standards. You will provide cross-functional technical leadership, support client and regulatory audits, and safeguard product quality and sterility.

You will lead contamination control and aseptic processing strategies, mentor teams, and ensure continued compliance with cGMP, FDA/EMA expectations, and Annex 1