Senior Analytical Scientist, Gene Therapy

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

Job summary

AskBio Inc. is seeking an Analytical Sciences & Technology leader to guide phase-appropriate analytical control strategies for gene therapy products. You will leverage scientific expertise to drive method development, validation, transfer, and lifecycle management across global programs.

Join a team delivering regulatory-ready analytics for IND/BLA submissions, enabling robust product characterization and lifecycle support in a matrix organization with GMP environments.

Qualifications

• Bachelor’s degree in biology, microbiology, molecular biology, biotechnology or related field with 8+ 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.

Responsibilities

• Lead analytical control strategies development for gene therapy products across programs, integrating regulatory expectations and product knowledge.
• Lead method transfers across CDMOs, CROs, and internal labs with knowledge transfer and sustained performance.
• Provide scientific oversight for complex analytical investigations (OOS, OOT, deviations) and CAPA workflows.
• Contribute to regulatory submissions (IND, BLA, MAA) with analytical input and lifecycle thinking.

Skills

Communication skills

Attention to detail

Problem solving

Cross-functional collaboration

Influence without authority

GMP experience

Education

Bachelor’s degree in biology, microbiology, molecular biology, biotechnology or related field

Master’s degree in related field

Job description

AskBio Inc. is seeking an Analytical Sciences & Technology leader to guide phase-appropriate analytical control strategies for gene therapy products. You will leverage scientific expertise to drive method development, validation, transfer, and lifecycle management across global programs.

Join a team delivering regulatory-ready analytics for IND/BLA submissions, enabling robust product characterization and lifecycle support in a matrix organization with GMP environments.