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

Jubilant Pharma, LLC; Spokane (WA); Presencial; USD 130.000 - 191.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical/Dental/Vision coverage

FSA/HSA availability

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Descripción de la vacante

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.

Formación

• 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.

Conocimientos

Leadership

Regulatory inspections

Quality risk mgmt

Aseptic processing

Environmental monitoring

cGMP compliance

Technology transfer

Educación

Bachelor’s degree in life sciences or engineering

Advanced degree (MS/PhD)

Descripción del empleo

Associate Director, Contamination Control Strategy (CCS) & Aseptic Process Simulation (APS) Job Description Job Alerts Link Job Title: Associate Director, Contamination Control Strategy (CCS) & Aseptic Process Simulation (APS) Req Id: 1927 Posting Start Date: 10/26/26 Job Description:

Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next

As Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

For the Builders, Innovators, and Doers — This Is Your Place

If you are someone who thrives onsolving complex problems, improving systems, and building real solutions, you’ll feel at home here. At Jubilant HollisterStier, your ideas matter — and your impact is felt globally.

Why builders choose us:

• Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well‑being shouldn’t have a waiting period.
• A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want tobuild something meaningful with a team that values your drive, skills, and ideas — you belong here.

Job Description:

The Associate Director, Aseptic Process Simulation (APS) and Contamination Control Strategy (CCS), owns and governs the JHS 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 JHS 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 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 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 JHS 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.

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.

Location: Spokane, WA — On Site, Full‑Time

Shift: Monday-Friday 8:00am-5:00pm

Compensation & Benefits That Start on Day One — Because Your Well Being Matters

Hiring Wage: $130,275 – $191,100 + 15% bonus annually, with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don’t believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting on your first day, you receive:

• 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

Unlock Your Potential

If you’re seeking a dynamic and rewarding career, we welcome your application today.

Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status,.

Our Promise: Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.

#INDJHS