Associate Scientist, AS&T

askbio; Durham (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

AskBio Inc., a Bayer subsidiary, is a focused gene therapy company advancing life-saving medicines across neuromuscular, CNS, cardiovascular, and metabolic diseases. The Analytical Sciences & Technology team leads phase-appropriate control strategies and robust analytical methods, integrating regulatory expectations and product knowledge to support lifecycle management.

The role emphasizes driving method development, transfer, validation, and data-driven decision making to ensure product quality

Qualifications

• Lead analytical method development and lifecycle management for gene therapy products.
• Apply statistical methods to evaluate assay performance and data quality.
• Coordinate transfers across CDMOs/CROs and internal QC labs to ensure robustness.

Responsibilities

• Lead analytical method transfers across external and internal labs.
• Oversee qualification, validation, transfer, and comparability strategies for programs.
• Interpret cross-program analytical data to guide decision-making and product understanding.
• Drive continuous improvement and adoption of new analytic approaches and technologies.
• Integrate regulatory expectations with analytical development and lifecycle support.

Skills

Analytical method development

Statistical data analysis

Cross-functional collaboration

Education

M.S. or Ph.D. in a relevant field

Tools

PCR/ddPCR

ELISA

NGS

HPLC

AUC

Job description

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.

Analytical support

• Lead the development and implementation of phase‑appropriate analytical control strategies for gene therapy products, integrating scientific expertise, regulatory expectations, and product knowledge to ensure robust product characterization and lifecycle support.
• Apply advanced scientific knowledge and broad analytical expertise to direct lifecycle management of complex bioanalytical methods, including but not limited to PCR/ddPCR, ELISA, cell‑based potency assays, NGS, HPLC, and AUC, driving method evolution, troubleshooting complex technical challenges, and enabling program objectives.
• Guide the design and execution of scientifically sound method qualification, validation, transfer, and comparability strategies for rAAV programs, leveraging comprehensive understanding of regulatory requirements, assay performance, and product development considerations.
• Integrate and interpret analytical data across multiple programs and functional disciplines to identify trends, assess method variability and provide strategic recommendations that support product quality, process understanding, and decision‑making.
• Apply statistical methodologies and scientific judgment to evaluate assay performance, capability, robustness, and lifecycle suitability, developing innovative approaches to address complex analytical challenges and improve data‑driven decision‑making.
• Drive continuous improvement and innovation in analytical sciences through the advancement of emerging technologies, digitalization, automation, and novel scientific approaches, guiding the development of new procedures, enhancing operational efficiency, and strengthening analytical capabilities across the organization

Tech transfer and external partner management

• Lead analytical method transfers across CDMOs, CROs, and internal QC laboratories, applying broad scientific expertise and strategic oversight to ensure successful implementation, knowledge transfer, and sustained method performance throughout the product lifecycle
• Author, review, and approve transfer protocols, validation strategies, technical reports, and scientific justifications, ensuring alignment with regulatory expectations, quality standards, and program objectives while advancing best practices in analytical sciences
• Serve as the Analytical Sciences & Technology (AS&T) subject matter expert for external partners, leveraging technical knowledge and cross‑functional understanding to establish scientific alignment, resolve complex analytical issues, and drive effective outcomes across organizational boundaries.
• Lead troubleshooting and resolution of cross‑site analytical challenges by integrating scientific principles, data‑driven approaches, and multidisciplinary expertise to ensure method consistency, robustness, comparability, and compliance across global laboratory networks.

Quality support

Provide scientific over