CMC AAV Gene Therapy Lead Scientist for BLA Readiness

OCUGEN OPCO INC; Malvern (Chester County); On-site; USD 180,000 - 280,000; Full time

Job summary

Ocugen seeks an experienced CMC leader to drive BLA-stage readiness for AAV gene therapy programs. The role serves as the strategic technical interface between lab development, GMP manufacturing, regulatory affairs, and program leadership to ensure seamless transition from clinical development to licensure.

You will lead CMC integration across DS, DP, analytical characterization, validation, and stability programs, coordinating data readiness to meet BLA timelines and preparing responses to FDA

Qualifications

• 10+ years in biologics or AAV gene therapy CMC development.
• Experience leading or contributing to BLA submissions.
• Deep knowledge of AAV manufacturing platforms.
• Strong program leadership and cross-functional execution.

Responsibilities

• Lead development and authoring of Module 3 content for BLA submission.
• Oversee DS/DP, analytical, validation, stability programs integration.
• Drive pre-approval inspection readiness and regulatory responses.
• Ensure process validation and CPV align with ICH Q8/Q9/Q10.

Skills

CMC leadership

Regulatory submissions

Cross-functional leadership

Gene therapy

AAV manufacturing

Education

PhD in Biochemical Engineering

MSc in Biotechnology

Job description

Ocugen seeks an experienced CMC leader to drive BLA-stage readiness for AAV gene therapy programs. The role serves as the strategic technical interface between lab development, GMP manufacturing, regulatory affairs, and program leadership to ensure seamless transition from clinical development to licensure.

You will lead CMC integration across DS, DP, analytical characterization, validation, and stability programs, coordinating data readiness to meet BLA timelines and preparing responses to FDA