QC Supervisor - Environmental Monitoring (Cell Therapy, First Shift)

QC Supervisor – Environmental Monitoring (Cell Therapy, First Shift)

Location: Portsmouth, NH, USA. The actual location of this job is in Portsmouth, NH, USA. Relocation assistance is available for eligible candidates and their families, if needed.

As the QC Supervisor for Cell Therapy Environmental Monitoring, you lead the critical team responsible for safeguarding our most sensitive manufacturing processes. In the world of Cell Therapy, where we handle patient-derived primary cells in a highly controlled environment, your oversight of microbial control is the final line of defense in ensuring patient safety and product sterility.

What You’ll Get

• High-Impact Leadership: Direct oversight of the quality environment for our fastest-growing and most life-changing asset.

• Strategic Influence: Own the site's environmental trending program and serve as the face of QC-EM in site-wide Quality Council meetings.

• Collaborative Culture: Work closely with First Shift production leadership to align sampling plans with active manufacturing schedules.

• Comprehensive Benefits: Medical, dental, vision, 401(k), and performance-based incentives. Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

What You’ll Do

• Cell Therapy Oversight: Manage the QC Microbiology team dedicated to environmental monitoring (routine and production-active) within the Cell Therapy suites.

• Aseptic Program Leadership: Provide oversight and ensure compliance of Grade B cleanroom monitoring and aseptic gowning qualification programs.

• Program Development: Develop site Environmental and Utility monitoring policies, ensuring sampling plans specifically account for the unique requirements of cell-based manufacturing.

• Trend Program Ownership: Own the site-wide trending program for the Cell Therapy asset. Host monthly meetings, share trend data with the site Quality Council, and identify/escalate adverse trends appropriately.

• Excursion Investigations: Lead and coach the team through high-complexity environmental excursion investigations. Ensure root cause analysis (RCA) is robust and that corrective actions keep the site in a state of control.

• Audit & Compliance: Represent the QC-EM department during internal and external audits, serving as the Subject Matter Expert (SME) for how we protect our cell therapy products from contamination.

• Capacity Management: Maintain tools for monitoring QC resource capacity. Provide feedback to management and production planners to ensure EM support aligns with manufacturing demands.

What We’re Looking For

• Education: Bachelor’s degree in a Scientific Discipline (Microbiology, Biology, or related field) is required.

• Experience: 5–10 years of advanced experience in Quality Control, with a strong focus on Environmental Monitoring and Aseptic Processing.

• Leadership Foundation: Some prior leadership experience is highly preferred

• Technical Mastery: Deep understanding of cGMP, microbial monitoring in Grade B/C/D cleanrooms, and the ability to interpret and present complex trending data to senior leadership.

• Communication: Exceptional verbal and written skills; ability to give oral presentations to customers and prepare high-level management reports.

• Schedule: Ability to work First Shift (Specific days and hours TBD).

About Lonza

At Lonza, our people are our greatest strength. In Cell Therapy, the work is personal—every batch represents a patient waiting for a breakthrough. We offer an inclusive and ethical workplace where your commitment to quality helps us turn breakthrough ideas into viable therapies.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. Lonza is proud to be an equal opportunity employer.

Ready to lead the next frontier of quality? Apply now.