BLA-Ready CMC Lead for AAV Gene Therapy

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

Job summary

Ocugen seeks an experienced CMC leader to drive BLA-stage readiness for AAV gene therapy programs. This role interfaces with laboratory development, GMP manufacturing, regulatory affairs, and program leadership to ensure seamless transition from clinical development to licensure.

The candidate will lead CMC integration across DS/DP, analytical characterization, process validation, and stability programs, and author Module 3 content for BLA submission while supporting FDA interactions.

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
• Potency assay development and validation
• 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
• Strong program leadership and cross-functional execution skills.

Responsibilities

• Lead development and authoring of CMC sections (Module 3) for BLA submission.
• Integrate DS, DP, analytical, validation, stability, and control strategy into cohesive regulatory narratives.
• Develop and justify: Control strategy and specification lifecycle
• Comparability frameworks (process changes, site transfers, scale-up)
• Process validation and PPQ strategy
• Coordinate data readiness across functions to meet BLA timelines.
• Lead preparation of responses to FDA information requests, late-cycle review questions, and potential Advisory Committee support.
• Oversee phase-appropriate transition to commercial-scale AAV manufacturing.
• Provide strategic oversight of: Process characterization studies
• Viral clearance (if applicable)
• PPQ protocol development and execution
• Continued Process Verification (CPV) planning
• Ensure control strategy is statistically justified and aligned with ICH Q8/Q9/Q10 principles.
• Drive readiness for pre-approval inspection (PAI).
• Provide Technical Leadership In Upstream (cell expansion, transfection/infection systems)
• Downstream purification (chromatography, TFF, clarification)
• Empty/full capsid ratio control
• Vector genome integrity and potency assays
• Ensure manufacturing consistency across clinical and commercial batches.
• Lead technical assessment of CPPs and CQAs.
• Oversee formulation optimization, aseptic fill-finish readiness, and container closure integrity.
• Ensure stability program supports shelf-life justification at BLA.
• Drive extractables/leachables, shipping validation, and in-use stability readiness.
• Lead Comparability Strategy Across Phase 1 to Phase 3 evolution
• Manufacturing scale changes
• Site transfers or CDMO transitions
• Develop risk-based justification when formal comparability protocols were not historically implemented.
• Ensure analytical depth supports regulatory defensibility.
• Serve as primary CMC integration lead across:Process Development, Analytical Development, MSAT, Quality, Regulatory Affairs
• Act as senior technical liaison with CDMOs, ensuring alignment on validation, documentation, and regulatory positioning.
• Maintain disciplined communication pathways for regulatory-sensitive decisions.

Skills

CMC leadership

BLA submissions

AAV manufacturing platforms

Potency assay development

Regulatory interactions

Cross-functional leadership

CDMO interface

Education

Ph.D. or Master’s in Biochemical Engineering/ Biotechnology/ Pharmaceutical Sciences

10+ years in biologics or AAV gene therapy CMC development

Job description

Ocugen seeks an experienced CMC leader to drive BLA-stage readiness for AAV gene therapy programs. This role interfaces with laboratory development, GMP manufacturing, regulatory affairs, and program leadership to ensure seamless transition from clinical development to licensure.

The candidate will lead CMC integration across DS/DP, analytical characterization, process validation, and stability programs, and author Module 3 content for BLA submission while supporting FDA interactions.