Senior Global AS&T Specialist

Position Summary

As a Senior Global Analytical Sciences and Technology (AS&T) Specialist at Ask Bio, you will support analytical method lifecycle management, troubleshooting, and method transfer activities from initial development to later phase clinical and commercial testing. You will operate effectively within a matrix organization with the ability to influence without direct authority across teams and functions supporting complex analytical methods and processes.

This office‑based position is located in Research Triangle Park, NC and reports to the Director, Analytical Sciences.

• Develop and implement phase‑appropriate analytical control strategies for gene therapy products
• Participate in lifecycle management of complex bioanalytical methods, including PCR/ddPCR, ELISA, cell‑based potency assays, NGS, HPLC, and AUC
• Support method qualification, validation, and comparability studies for rAAV program methods
• Analyze analytical data across programs to identify trends, method variability, and product consistency
• Apply statistical tools to evaluate assay performance and capability
• Drive continuous improvement initiatives for analytical technologies, including digitalization and automation

• Participate in or lead analytical method transfers to/from CDMOs, CROs, and internal QC laboratories
• Author and approve transfer protocols, validation documents, and technical reports
• Act as the AS&T SME for external partners, ensuring alignment on method performance and expectations
• Troubleshoot cross‑site method activities, ensuring consistency across global networks

• Support investigations (OOS/OOT/deviations) and assist in determination of root‑cause analysis of complex analytical methods
• Partner with Quality to define and implement CAPAs and ensure inspection‑readiness

• Author and review analytical sections of regulatory submissions (IND, BLA, MAA), with emphasis on gene therapy requirements
• Ensure analytical control strategies align with evolving regulatory expectations for advanced therapies
• Support regulatory interactions, inspections, and responses as an analytical SME

• Bachelor’s degree in biology, microbiology, molecular biology, biotechnology or related field with 5+ years of relevant work experience, or a Master’s degree with 2+ 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 of 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

• 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

Ask Bio Inc. (Ask Bio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‑related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561‑6210 or sending us an email at