Analytical Scientist - Gene Therapy Analytics

AskBio Inc.; Durham (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

AskBio Inc. is seeking a Senior Analytical Scientist to lead method development, validation, and lifecycle support for its gene therapy programs.

You will manage cross-functional teams, ensure GMP compliance, and drive robust lifecycle management of analytical methods across clinical and commercial programs. Key responsibilities include technology transfer to CROs/CDMOs, investigations of analytical deviations, and regulatory submissions support with a focus on ICH/FDA/EMA guidelines for

Qualifications

• Bachelor’s degree in biology or related field with 8+ years in analytical sciences.
• Experience in GMP environments and cross-functional programs.
• Ability to influence without direct authority across teams and functions.
• Knowledge of analytical methods supporting biologics manufacturing.
• Excellent written and verbal communication skills.
• Understanding ICH, FDA, and EMA requirements for gene therapies.

Responsibilities

• Lead analytical method development and validation for gene therapy programs across lifecycle stages.
• Oversee tech transfer of analytical methods to CDMOs, CROs, and internal labs.
• Provide scientific oversight for investigations (OOS, OOT) and CAPA programs.
• Contribute to regulatory submissions by authoring analytical sections and responding to inquiries.
• Collaborate with Quality, Manufacturing, and Regulatory teams to ensure compliance and data integrity.

Skills

GMP environments

Analytical method development

Method validation

Tech transfer

Regulatory knowledge (ICH/FDA/EMA)

Data analysis

Education

Bachelor’s degree in biology or related field

Master’s degree in a related discipline

Job description

AskBio Inc. is seeking a Senior Analytical Scientist to lead method development, validation, and lifecycle support for its gene therapy programs.

You will manage cross-functional teams, ensure GMP compliance, and drive robust lifecycle management of analytical methods across clinical and commercial programs. Key responsibilities include technology transfer to CROs/CDMOs, investigations of analytical deviations, and regulatory submissions support with a focus on ICH/FDA/EMA guidelines for