Senior Global AS&T Specialist

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

• [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

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10 , an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people’s lives.

Our principles:

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.