CMC Lead for AAV Gene Therapy — BLA Readiness

Ocugen; Malvern (Chester County); On-site; USD 180,000 - 240,000; Full time

Job summary

Ocugen in Malvern, PA seeks an experienced CMC leader to drive BLA-stage readiness for AAV gene therapy programs. You will bridge development, GMP manufacturing, regulatory affairs, and program leadership to ensure a smooth transition from clinical development to licensure.

You will author Module 3 content, oversee DS/DP, analytics, stability, and validation, and support regulatory interactions through approval. This high-visibility role requires deep AAV manufacturing and lifecycle expertise.

Qualifications

• Ph.D. (preferred) or Master’s in Biochemical Engineering, Biotechnology, Pharmaceutical Sciences, or related field.
• 10+ years in biologics or AAV gene therapy CMC development.
• Direct experience leading or significantly contributing to BLA-stage submissions.
• Deep knowledge of AAV manufacturing platforms and potency assay development.
• PPQ and process validation for biologics; stability and shelf-life justification.
• Regulatory expectations for gene therapy products; experience supporting FDA meetings and pre-approval inspections.

Responsibilities

• Lead development and authoring of CMC sections (Module 3) for BLA submission.
• Integrate DS, DP, analytical, validation, stability, and control strategies into regulatory narratives.
• Develop control strategy lifecycle and comparability frameworks.
• Coordinate data readiness across functions to meet BLA timelines.
• Lead responses to FDA information requests and potential Advisory Committee support.
• Provide strategic oversight of process characterization, viral clearance, PPQ protocol, CPV planning.
• Drive pre-approval inspection readiness and ensure manufacturing consistency across batches.

Skills

CMC leadership

BLA submissions

GMP manufacturing

Regulatory affairs

Cross-functional leadership

AAV manufacturing

PPQ strategy

Statistical analysis

Education

Ph.D. (preferred)

Job description

Ocugen in Malvern, PA seeks an experienced CMC leader to drive BLA-stage readiness for AAV gene therapy programs. You will bridge development, GMP manufacturing, regulatory affairs, and program leadership to ensure a smooth transition from clinical development to licensure.

You will author Module 3 content, oversee DS/DP, analytics, stability, and validation, and support regulatory interactions through approval. This high-visibility role requires deep AAV manufacturing and lifecycle expertise.