Senior Global AS&T Specialist
About The Position
AskBio Inc., a subsidiary of Bayer AG, is a gene therapy company focused on developing life-saving medicines. The company has a pipeline of investigational therapeutics for various diseases and a proprietary gene therapy platform. This role is for a Senior Global Analytical Sciences and Technology (AS&T) Specialist who will support analytical method lifecycle management, troubleshooting, and method transfer activities. The specialist will operate effectively in a matrix organization, influencing without direct authority. This is an office-based position in RTP, NC, reporting to the Director, Analytical Sciences.
Requirements
- 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 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.
Nice To Haves
- 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
