Analytical support

• Lead the development and implementation of phase-appropriate analytical control strategies for gene therapy products, integrating scientific expertise, regulatory expectations, and product knowledge to ensure robust product characterization and lifecycle support.

• Apply advanced scientific knowledge and broad analytical expertise to direct lifecycle management of complex bioanalytical methods, including but not limited to PCR/ddPCR, ELISA, cell-based potency assays, NGS, HPLC, and AUC, driving method evolution, troubleshooting complex technical challenges, and enabling program objectives.

• Guide the design and execution of scientifically sound method qualification, validation, transfer, and comparability strategies for rAAV programs, leveraging comprehensive understanding of regulatory requirements, assay performance, and product development considerations.

• Integrate and interpret analytical data across multiple programs and functional disciplines to identify trends, assess method variability and provide strategic recommendations that support product quality, process understanding, and decision-making.

• Apply statistical methodologies and scientific judgment to evaluate assay performance, capability, robustness, and lifecycle suitability, developing innovative approaches to address complex analytical challenges and improve data-driven decision-making.

• Drive continuous improvement and innovation in analytical sciences through the advancement of emerging technologies, digitalization, automation, and novel scientific approaches, guiding the development of new procedures, enhancing operational efficiency, and strengthening analytical capabilities across the organization

Tech transfer and external partner management

• Lead analytical method transfers across CDMOs, CROs, and internal QC laboratories, applying broad scientific expertise and strategic oversight to ensure successful implementation, knowledge transfer, and sustained method performance throughout the product lifecycle

• Author, review, and approve transfer protocols, validation strategies, technical reports, and scientific justifications, ensuring alignment with regulatory expectations, quality standards, and program objectives while advancing best practices in analytical sciences

• Serve as the Analytical Sciences & Technology (AS&T) subject matter expert for external partners, leveraging technical knowledge and cross-functional understanding to establish scientific alignment, resolve complex analytical issues, and drive effective outcomes across organizational boundaries.

• Lead troubleshooting and resolution of cross-site analytical challenges by integrating scientific principles, data-driven approaches, and multidisciplinary expertise to ensure method consistency, robustness, comparability, and compliance across global laboratory networks.

Quality support

• Provide scientific oversight for complex analytical investigations, including OOS, OOT, and deviation events, applying technical expertise, data-driven methodologies, and multidisciplinary knowledge to aid in the identification of root causes, assess impact, and develop effective resolution strategies.

• Partner with Quality, Manufacturing, Regulatory, and other functional areas to  develop, and implement, scientifically sound CAPAs, ensuring sustainable improvements, operational excellence, compliance, and alignment with company objectives.

• Drive inspection readiness by providing scientific leadership in the evaluation, documentation, and resolution of analytical quality events, ensuring robust investigation practices, regulatory compliance, and continuous improvement across the analytical lifecycle.

Regulatory

• Author and review analytical sections of global regulatory submissions (IND, BLA, MAA), leveraging expertise in analytical control strategies and regulatory requirements to support successful product development and registration

• Participate in the development and continuous evolution of analytical control strategies, integrating multidisciplinary scientific insights, product knowledge, and emerging regulatory guidance to ensure robust product quality, control, and lifecycle management.

• Support regulatory interactions, inspections, and responses as an analytical SM

Minimum Requirements

• Bachelor’s degree in biology, microbiology, molecular biology, biotechnology or related field with 8+ years of relevant work experience, or a Master’s degree with 4+ years of relevant work experience

• Demonstrated experience working in matrix organizations and independent management of cross-functional initiatives

• Ability to influence without direct authority across teams and functions

• Hands-on experience supporting GMP environments

• Experience with method validation, transfer, and lifecycle management

• Knowledge of analytical methods supporting biologics manufacturing

• Understanding ICH, FDA, and EMA requirements for gene therapy products.

• Excellent written and verbal communication skills

• High attention to detail and data integrity mindset

• Strong problem-solving and investigative skills

Preferred Education, Experience and Skills

• Industry experience with strong focus on gene therapies analytical methodologies

• Experience with stability studies and impurity profiling

• Project management and prioritization skills

• Experience supporting regulatory filings and agency interactions

• Knowledge of Quality by Design (QbD) and risk-based approaches