Senior Global AS&T Specialist

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 Parkinsons disease and Pompe disease. AskBios 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 peoples 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 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 whats right in every situation. Make clear commitments and follow through.

Position Summary

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

Minimum Requirements

• Bachelors degree in biologymicrobiologymolecularbiologybiotechnology or related field with 5 years of relevant work experience or a Masters 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. (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 jobrelated 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 or sending us an email at .

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.