Senior Director, CMC Tech Lead: AAV Gene Therapy

Neurogene Inc.; Houston (TX); Hybrid; USD 250.000 - 350.000; Vollzeit

Zusammenfassung

Neurogene Inc. is seeking a Senior Director, CMC Technical Lead to own the integrated control strategy for the lead AAV program, ensuring scientific defensibility of Module 3 through PPQ and readiness for BLA preparation.

The role collaborates across Analytical Development, Process Development, MSAT, QC, QA, and Regulatory CMC, chairs the CMC Technical Review Board, and partners with Regulatory to translate technical positions into filing-ready content.

Qualifikationen

• PhD in a relevant scientific or engineering discipline.
• 10+ years in biologics or advanced-therapy CMC.
• Experience authoring at least one BLA/MAA Module 3 for a biologic.
• Hands-on familiarity with AAV manufacturing and analytical characterization.
• Experience with PPQ and commercial launch of biologic/advanced therapy.
• Knowledge of ICH guidelines and FDA/EMA expectations.

Aufgaben

• Own the integrated control strategy and CQAs/CPPs linkage.
• Integrate the technical story across functions to present one narrative.
• Craft the Module 3 technical narrative for BLA.
• Lead comparability strategy across PPQ and changes.
• Chair the CMC Technical Review Board.
• Support BLA authoring and health-authority interactions.
• Oversee reference-standard strategy and release/specifications.
• Bridge process science to commercial readiness.
• Provide senior technical advisory to SVP and CMC leadership.
• Maintain independence of Quality decisions and Regulatory ownership.

Jobbeschreibung

Neurogene Inc. is seeking a Senior Director, CMC Technical Lead to own the integrated control strategy for the lead AAV program, ensuring scientific defensibility of Module 3 through PPQ and readiness for BLA preparation.

The role collaborates across Analytical Development, Process Development, MSAT, QC, QA, and Regulatory CMC, chairs the CMC Technical Review Board, and partners with Regulatory to translate technical positions into filing-ready content.