Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Principal Engineer I in MSAT will provide technical leadership to support both early- and late-stage AAV GMP manufacturing at internal and contract gene therapy facilities. Reporting to the Sr. Director of MSAT, this role will focus on developing data management solutions to enable monitoring the ongoing GMP production and drive process improvements for future lifecycle management. The ideal candidate will bring a strong foundation in biologics/AAV process knowledge combined with statistical expertise. Success in this role requires a high degree of professionalism, cross-functional collaboration, and an innovative mindset.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

• Build and implement the Continued Process Verification (CPV) framework for AAV programs, including online/offline data management solutions, data integrity verification process, statistical tools and predictive models to monitor and improve batch performance.
• Establish and oversee systems for data collection, monitoring, and analysis systems for early and late-stage programs, ensuring compliance with 21 CFR Part 11 and alignment with regulatory expectations.
• Develop and apply advanced statistical data modeling approaches (e.g., multivariate analysis, regression, machine learning techniques) to enable predictive modeling, deviation investigations and continuous improvement.
• Support deviation investigations and tech transfer activities by leveraging statistical expertise to analyze historical data, and to set or revise in-process control limits.
• Lead initiatives to develop platform process models (HEK vs. HeLa) across multiple GMP manufacturing sites to support proactive process monitoring; stay current with the AAV manufacturing technology innovations, and support implementation of process improvements for life cycle management.
• Collaborate with Global CMC Development, external CDMOs, Manufacturing, Quality Assurance, Quality Control, and other stakeholders to enable robust CPV strategy execution.
• Contribute to regulatory filings by authoring CPV-related content, responding to agency inquiries, and authoring sections of briefing books and submissions.
• Author and maintain technical documentation, including CPV protocols and reports, statistical models, SOPs for data management, and lifecycle management protocols and reports.

Requirements:

• Master’s degree in Virology, Molecular Biology, Genetics, Biochemistry, Chemical Engineering, Bioinformatics, Biostatistics or an equivalent discipline preferred
• 5+ years in biopharma industry. Biologics, Gene / Cell therapy experience preferred
• Understanding of biologics/AAV manufacturing process is required and experience in manufacturing technical support, process development, and/or MSAT roles is preferred
• Demonstrated experience in data management, process modeling, and predictive analytics, preferred with GMP environment
• Proficiency in biostatistics and data management tools (e.g., DOE, multivariate analysis, regression, Python/R/SAS).
• Experience with regulatory filing is a plus
• Proven ability to deliver results successfully, collaborating with multi-cultural and geographically diverse teams
• Demonstrated ability to work in a team and in a fast-paced environment. Proven ability to independently manage multiple competing priorities, while working on multiple projects simultaneously
• Excellent communication and presentation skills
• May require up to 15% travel when necessary. #LI-CK1 #LI-Onsite