Associate Director, Aseptic Process Simulation (APS) and Contamination Control Strategy (CCS)
About the role
Jubilant HollisterStier LLC, Spokane’s largest pharmaceutical manufacturing company, is seeking an Associate Director, Aseptic Process Simulation (APS) and Contamination Control Strategy (CCS). The role owns and governs the APS and CCS programs, establishes site standards, and drives continuous improvement to ensure best‑in‑class performance for a multi‑product CDMO. As the site subject‑matter expert and technical leader, you will provide strategic, cross‑functional leadership to maintain regulatory compliance, support client and regulatory audits, and safeguard product quality, sterility assurance, and patient safety.
Responsibilities
- Own and govern JHS APS and CCS programs, setting and maintaining internal standards.
- Continuously optimize programs to be best in class compared to industry standards.
- Oversee governance for site APS and CCS programs.
- Support client and regulatory audits and maintain NAI or VAI stance for the site.
- Represent JHS as an industry SME on CCS/APS.
- Partner with cross‑functional site leaders and provide technical leadership in CCS/APS.
- Report CCS/APS performance metrics to team and site leadership.
- Manage and supervise resources dedicated to CCS/APS, delegating tasks to TS resources.
- Ensure all TS tasks associated with CCS/APS are completed on time.
- Support or delegate resources for investigation and impact assessment of APS/CCS‑related deviations.
- Perform 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.
- 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).
- 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.
- 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 (e.g., ASQ CQE/CQA, PDA aseptic processing training).
- Lean Six Sigma (Green or Black Belt) certification.
Working Environment
Standard office environment for documentation, data review, and meetings. May require occasional off‑shift or weekend presence to support media fills, investigations, or inspections.
Schedule
On‑site, full‑time in Spokane, WA. Monday‑Friday, 8:00 am – 5:00 pm. Occasional off‑shift or weekend work may be required.
Compensation & Benefits
Hiring wage: $130,275 – $208,400 annually, with opportunities for growth, promotion, and annual raises.
Benefits start on day one:
- Medical, Dental & Vision coverage
- Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
- Life & AD&D Insurance
- Short‑Term & Long‑Term Disability Insurance
- Employee Assistance Program