Ishan Gujrathi
Senior Specialist Manufacturing Compliance @Jubilant HollisterStier CMO
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WORK HISTORY
Senior Specialist Manufacturing Compliance @Jubilant HollisterStier CMO
Spokane, WA, US
Supporting aseptic sterile injectable manufacturing operations within SVP Aseptic 1, with a focus on ensuring robust cGMP compliance, inspection readiness, and operational excellence across manufacturing activities.Key responsibilities include- Providing day-to-day manufacturing compliance support for aseptic operations, ensuring alignment with FDA, cGMP, and internal quality standards- Leading and supporting deviation investigations, CAPAs, change controls, and risk assessments related to SVP Aseptic 1 operations- Partnering closely with Manufacturing, Quality, Engineering, Validation, and Packaging teams to embed compliance into routine operations- Supporting audit and inspection readiness, including documentation review, data integrity checks, and inspection response preparation- Driving continuous improvement initiatives to strengthen procedural adherence, documentation quality, and operational reliability in aseptic environments- This role enables me to work at the intersection of compliance, manufacturing, and quality, directly supporting safe, reliable, and compliant production of sterile injectable products.
EDUCATION
University of Mumbai
Honours, Sustainability Studies
University of Mumbai
Bachelor of Technology - BTech, Chemical Engineering
Illinois Institute of Technology
Master of Engineering management , Product design and development
ABOUT ISHAN GUJRATHI
Hi, I’m Ishan Gujrathi a Chemical Engineer with a Master’s in Engineering Management from Illinois Institute of Technology, driven by a strong interest in manufacturing excellence, regulatory compliance, and data-driven operational improvement within regulated industries.I currently work at Jubilant HollisterStier as a Senior Specialist, Compliance, supporting sterile injectable manufacturing operations. My work sits at the intersection of GMP compliance, quality systems, and manufacturing operations, where I collaborate cross-functionally to ensure regulatory adherence while driving continuous improvement.My experience spans inspection and packaging operations, business excellence initiatives, and Six Sigma–driven process optimization. I have worked extensively with high-speed fill-finish and inspection lines (including Dabrico and Seidenader), focusing on deviation management, CAPAs, change control, audit readiness, and improving documentation and data integrity. I approach compliance not just as a requirement, but as a lever for operational reliability, efficiency, and patient safety.Previously, I’ve:Supported process improvement and compliance tracking across manufacturing operationsWorked on utilities optimization and water allocation systems supporting municipal infrastructureLed cross-functional initiatives spanning operations, quality, and engineeringBuilt and scaled a consumer product venture with 200% YoY revenue growth, strengthening my business and execution mindset Core Strengths• Manufacturing Compliance & Quality Systems (cGMP, FDA)• Lean Six Sigma & Continuous Improvement (Green Belt)• Deviation Management, CAPA, Change Control & Risk Management• Data Analytics (Excel, Power BI, Python, SAP)• Cross-functional Collaboration & Operational Strategy• Sustainable & Efficient Manufacturing SystemsI thrive in environments where compliance, operations, and improvement intersect, and I’m motivated by work that directly impacts product quality, regulatory confidence, and patient outcomes.Always open to connecting with professionals passionate about manufacturing excellence, quality, and scalable systems in pharma, biotech, and regulated manufacturing.
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