Associate Director, Contamination Control Strategy (CCS) & Aseptic Process Simulation (APS)

ALKU; Spokane (WA); On-site; USD 180,000 - 240,000; Full time

Job summary

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

Qualifications

• 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).

Responsibilities

• 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.

Skills

Leadership

People management

Regulatory inspections

Cross-functional collaboration

Technical leadership

Education

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

MS or PhD preferred

Job description

Associate Director, Contamination Control Strategy (CCS) & Aseptic Process Simulation (APS)

The Associate Director, Contamination Control Strategy (CCS) & Aseptic Process Simulation (APS), owns and governs the company APS and CCS programs, establishing site standards and driving continuous improvement to ensure best-in-class performance for a multi-product CDMO. As the site subject matter expert and technical leader for contamination control and aseptic processing, this role provides strategic, cross-functional leadership to maintain a state of favorable regulatory compliance, represents the company as an industry-recognized expert in APS and CCS, and supports successful client and regulatory audits while safeguarding product quality, sterility assurance, and patient safety.

• 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.

Qualifications:

Required:

• Bachelor’s degree in Microbiology, Pharmacy, Chemistry, Biology, Chemical or Biomedical Engineering, or a related life science or engineering discipline.
• 10+ years in sterile / aseptic pharmaceutical manufacturing within a cGMP environment.
• Demonstrated expertise in contamination control, aseptic processing, and media fill / APS programs.
• Proven track record supporting and presenting during regulatory inspections (e.g., FDA, EMA) and customer audits.
• Several years in a leadership or people-management capacity.
• Mastery in Contamination Control Strategy and quality risk management (Annex 1).
• Mastery in Aseptic processing and APS / media fill design (PDA TR 22).
• Functional Expert in Environmental and personnel monitoring / microbiology (USP <1116>).
• Functional Expert in cGMP and regulatory inspection management (FDA, EMA, 21 CFR 210/211).
• Functional Expert in Process validation, continued process verification (CPV), and technology transfer.
• Functional Expert in Deviation / CAPA, change control, and root cause analysis.
• Functional Expert in Sterile manufacturing technologies (isolator / RABS, fill-finish, lyophilization).

Preferred:

• Advanced degree (MS or PhD) in a relevant scientific discipline preferred.
• SME-level knowledge of EU GMP Annex 1 and current aseptic processing expectations.
• Experience authoring or owning a site Contamination Control Strategy aligned to Annex 1.
• Experience in a CMO / CDMO environment serving multiple clients and products.
• Hands‑on experience with isolator and RABS technology, fill‑finish, and lyophilization.
• Experience leading technology transfer and new product introduction (NPI) projects.
• Quality or aseptic processing credentials desirable (e.g., ASQ CQE/CQA, PDA aseptic processing training).
• Lean Six Sigma (Green or Black Belt) desirable.
• Standard office environment for documentation, data review, and meetings.
• May require occasional off‑shift or weekend presence to support media fills, investigations, or inspections.