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

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

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 on solving 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.

Job Description

• 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 ).
• 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 – $208,400 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.