QC Principal Scientist - Microbiology (Cell Therapy)

What You’ll Get

• Technical Authority: Serve as a primary SME for Microbiology, influencing site-wide quality strategy and representing the department in cross-functional leadership teams.
• Complex Problem Ownership: Lead high-visibility investigations and continuous improvement projects that directly impact the efficiency and compliance of the Cell Therapy asset.
• Audit Leadership: Play a key role in regulatory inspections, acting as a primary technical witness and SME in both front and back-room settings.

What You’ll Do

• Validation & Method Transfer: Lead the authoring and execution of protocols for method transfers, qualifications, and validations. Identify technical risks and implement mitigation strategies to ensure on-time program completion.
• Technical SME Oversight: Provide expert guidance to internal operations and contracted suppliers across a broad spectrum of microbiology disciplines. Be the technical resource for cross-functional teams involving Manufacturing and Quality Assurance.
• Audit Participation: Actively participate in internal and external audits (FDA, EMA, etc.). Defend technical data, explain complex microbial processes, and support the "back-room" strategy team.
• Investigation Leadership: Perform and lead high-complexity deviation and investigation activities. Apply root cause analysis (RCA) to identify systemic issues and implement effective CAPAs.
• Compliance & Review: Perform high-level review of laboratory records and author/approve QC SOPs, protocols, and specifications to ensure 100% adherence to cGMP and global regulatory guidelines (USP, EP, JP).
• Data Mining & Trending: Troubleshoot assay and instrumentation issues through advanced data mining and trend analysis to support long-term laboratory operational health.

About the Role

This is a high-level individual contributor role that acts as a technical advisor to site leadership and a mentor to junior staff, ensuring our personalized therapies meet global regulatory standards through scientific excellence.

Full Lonza Benefits

• Medical
• Dental
• Vision
• 401(k)
• Performance-based incentives

Who We’re Looking For

• Education: Bachelor’s degree in Microbiology, Biochemistry, or a related Science discipline is required. An Advanced Graduate Degree (Master’s or PhD) is highly preferred.
• Experience: 5–10+ years of relevant experience in a professional GMP environment. You should have a proven track record of managing complex QC projects and leading technical investigations.
• Technical Mastery: * Broad Microbiological Expertise: Extensive knowledge across multiple disciplines, including Sterility Testing, Endotoxin analysis, and Microbial ID/Genomics.
• * Regulatory Fluency: Expert knowledge of cGMP principles and global pharmacopeia (USP, EP, JP).
• * Systems Proficiency: Advanced experience with Quality Systems such as TrackWise and LIMS.
• * Soft Skills: * Analytical Leadership: Ability to mentor junior staff and resolve technical problems with little to no day-to-day instruction.
• * Strategic Communication: Strong ability to organize technical information into logical, coherent reports and present with confidence to site leadership and regulatory auditors.
• * Initiative: A champion for change who drives successful implementation of new initiatives.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.