Senior Global AS&T Specialist

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

4d•Onsite

About The Position

This role is a secondment opportunity at AskBio, a company focused on advancing gene therapy. The Senior Global Analytical Sciences and Technology (AS&T) Specialist will support analytical method lifecycle management, troubleshooting, and method transfer activities for gene therapy products. The position requires operating effectively within a matrix organization and 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.