AAV CMC Technical Lead & Regulatory Strategy Director

Scorpion Therapeutics; Houston (TX); Hybrid; USD 300,000 - 420,000; Full time

Benefits offered by this job

Biologics

AAV gene therapy

CMC development

BLA Module 3

Regulatory strategy

Process characterization

PPQ

Commercial launch

Job summary

Scorpion Therapeutics is seeking a Senior Director, CMC Technical Lead for AAV gene therapy to oversee the technical integrity and regulatory narrative of Module 3 in BLA submissions. The role connects Analytical Development, Process Development, MSAT, Quality Control, and Quality Assurance to ensure an integrated control strategy.

You will author regulatory content, lead the comparability strategy and risk assessments, chair the CMC Technical Review Board, and support agency interactions.

Qualifications

• PhD in a relevant scientific or engineering discipline
• 10+ years in biologics or advanced therapies CMC, with experience in AAV manufacturing, analytical characterization, and regulatory submissions
• Proven expertise in control strategies, regulatory inspections, and process validation

Responsibilities

• Own and connect the integrated control strategy across Analytical Development, Process Development, MSAT, Quality Control, and Quality Assurance
• Author and integrate the technical content for regulatory filings
• Lead the comparability strategy and risk assessments
• Chair the CMC Technical Review Board
• Support BLA authoring and agency interactions
• Ensure process understanding transitions to commercial manufacturing
• Serve as a technical authority in cross-functional decisions without direct reports

Job description

Scorpion Therapeutics is seeking a Senior Director, CMC Technical Lead for AAV gene therapy to oversee the technical integrity and regulatory narrative of Module 3 in BLA submissions. The role connects Analytical Development, Process Development, MSAT, Quality Control, and Quality Assurance to ensure an integrated control strategy.

You will author regulatory content, lead the comparability strategy and risk assessments, chair the CMC Technical Review Board, and support agency interactions.