Senior Analytical Scientist, Gene Therapy Analytics

Asklepios Biopharmaceutical Inc; Durham (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

AskBio Inc. is a gene therapy company focused on analytical sciences, lifecycle management, and regulatory engagement. The role supports cross-functional teams to advance method qualification, validation, and comparability for rAAV programs.

You will guide method transfers, investigations, and regulatory interactions across a global network. We seek candidates with a strong GMP background and expertise in analytical control strategies, QC, and lifecycle management.

Qualifications

• 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.
• Excellent written and verbal communication skills.
• High attention to detail and data integrity mindset.
• Strong problem-solving and investigative skills.

Responsibilities

• Lead analytical method transfers across CDMOs, CROs, and internal QC laboratories.
• Author, review, and approve transfer protocols, validation strategies, and technical reports.
• Provide scientific oversight for complex analytical investigations (OOS, OOT, deviations).
• Regulatory support for analytical control strategies in submissions (IND, BLA, MAA).
• Drive continuous improvement through new procedures and technologies.

Skills

Matrix organizations

Influence without authority

GMP environments

Communication skills

Problem-solving

Attention to detail

Education

Bachelors in biology/molecular biology/related

Master's degree in related field

Job description

AskBio Inc. is a gene therapy company focused on analytical sciences, lifecycle management, and regulatory engagement. The role supports cross-functional teams to advance method qualification, validation, and comparability for rAAV programs.

You will guide method transfers, investigations, and regulatory interactions across a global network. We seek candidates with a strong GMP background and expertise in analytical control strategies, QC, and lifecycle management.