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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Global AS&T Specialist - **Company:** Asklepios Biopharmaceutical, Inc. - **Location:** Durham, NC, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Data Integrity, Model Validation - **Published:** July 2, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=8d55978edcee49a1 ## About the Role * [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 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 ## Description As a Senior Global Analytical Sciences and Technology (AS&T) Specialist with AskBio, you will be responsible for supporting analytical method lifecycle management, troubleshooting, and method transfer activities from initial development to later phase clinical and commercial testing sites. You will be skilled at operating effectively within a matrix organization with the ability to influence without direct authority across teams and functions supporting complex analytical methods and processes. This is an office-based position in RTP, NC and reports to the Director, Analytical Sciences. Job Responsibilities Analytical support * 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 Tech transfer and external partner management * 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 Quality support * 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 Regulatory * 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 ## Related Videos - [Introduction to Responsible AI: Balancing Value and Risk](https://www.wearedevelopers.com/videos/1972-introduction-to-responsible-ai-balancing-value-and-risk) - [Exploring 5 Key Applications of AI Abundance with Blockchain Assurance](https://www.wearedevelopers.com/videos/971-exploring-5-key-applications-of-ai-abundance-with-blockchain-assurance) - [Geometric deep learning for drug discovery](https://www.wearedevelopers.com/videos/264-geometric-deep-learning-for-drug-discovery) - [Building Trustworthy AI in Industry: Beyond Traditional Cybersecurity](https://www.wearedevelopers.com/videos/1948-building-trustworthy-ai-in-industry-beyond-traditional-cybersecurity) - [Startup Presentation: StorX - Future of Cloud Storage](https://www.wearedevelopers.com/videos/1176-startup-presentation-storx-future-of-cloud-storage) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) ## Related Articles - [Data Analyst Salary Germany](https://www.wearedevelopers.com/magazine/277-data-analyst-salary-germany) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Starter Kit For Job Applications For Developers](https://www.wearedevelopers.com/magazine/7-starter-kit-for-job-applications-for-developers) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [Best Companies to Work For in Germany: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/33-best-companies-to-work-for-in-germany-top-25-companies-in-2023)