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Durham, North Carolina, United States
Onsite
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 oversight for complex analytical investigations, including OOS, OOT, and deviation events, applying technical expertise, data-driven methodologies, and multidisciplinary knowledge to aid in the identification of root causes, assess impact, and develop effective resolution strategies.
Partner with Quality, Manufacturing, Regulatory, and other functional areas to develop, and implement, scientifically sound CAPAs, ensuring sustainable improvements, operational excellence, compliance, and alignment with company objectives.
Drive inspection readiness by providing scientific leadership in the evaluation, documentation, and resolution of analytical quality events, ensuring robust investigation practices, regulatory compliance, and continuous improvement across the analytical lifecycle.
Regulatory
Author and review analytical sections of global regulatory submissions (IND, BLA, MAA), leveraging expertise in analytical control strategies and regulatory requirements to support successful product development and registration
Participate in the development and continuous evolution of analytical control strategies, integrating multidisciplinary scientific insights, product knowledge, and emerging regulatory guidance to ensure robust product quality, control, and lifecycle management.
Support regulatory interactions, inspections, and responses as an analytical SM
Minimum Requirements
Bachelor’s degree in biology, microbiology, molecular biology, biotechnology or related field with 8+ years of relevant work experience, or a Master’s degree with 4+ 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. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.
Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.
