Senior Director, CMC Technical Lead
Position Overview
The Senior Director, CMC Technical Lead is a senior individual-contributor role responsible for the technical integrity of the drug product and for connecting the technical narrative across Analytical Development, Process Development, MSAT, Quality Control, and Quality Assurance. This role owns the integrated control strategy and the technical narrative of Module 3, and is accountable for their scientific defensibility as the lead AAV gene therapy program advances through Process Performance Qualification (PPQ), BLA preparation, and commercial launch.
Requirements
Own the integrated control strategy — serve as the single technical owner of the end-to-end control-strategy narrative, connecting critical quality attributes (CQAs) to critical process parameters (CPPs), in-process controls, and release and stability specifications, with clearly documented criticality logic for each linkage.
Integrate the technical story across functions — connect the scientific narrative across Analytical Development, Process Development, MSAT, Quality Control, and Quality Assurance so that Module 3 presents one internally consistent technical argument.
Craft the BLA / Module 3 technical narrative — author and integrate the technical content and scientific justification for CTD Module 3 sections (e.g., S.2.6, P.2, specification and process-characterization justifications), ensuring the process characterization PPQ CPV storyline is coherent and inspection-ready.
Lead comparability strategy — define and steward the comparability strategy across process changes and PPQ, ensuring technical consistency and regulatory defensibility.
Ensure criticality and risk-assessment consistency — ensure CQA and CPP risk assessments and rankings are scientifically sound and internally consistent across all functional inputs.
Chair the CMC Technical Review Board — chair the cross-functional governance body where BLA technical decisions are made and recorded, driving timely, evidence-based resolution of cross-functional technical issues.
Support BLA authoring and health-authority interactions — partner with Regulatory CMC to translate technical positions into filing-ready content and to prepare responses to health-authority questions and pre-approval inspection queries; serve as a technical subject-matter expert in agency interactions.
Own reference-standard strategy and specification justification — oversee the technical basis for the reference-standard strategy and the scientific justification of release and stability specifications.
Bridge process science to commercial readiness — ensure process and analytical understanding developed through characterization and PPQ is carried into the control strategy and lifecycle management (CPV) as the program transitions to commercial supply.
Serve as senior technical advisor — act as a senior individual-contributor technical authority to the SVP, Technical Operations and the CMC leadership team, leading through defined decision rights rather than direct line management of the contributing functions.
Uphold Quality and Regulatory independence — integrate the technical narrative while preserving the independence of Quality decisions (batch disposition, deviation classification, GMP approvals) and Regulatory ownership of filing strategy and agency commitments.
Essential Details
Manufacturing ONLY
Travel
Safety
Quality Responsibility
Scope
Leadership Responsibility
Minimum Requirements
Education
Experience
Licenses or Certifications
Knowledge, Skills And Attributes