Product Quality Director - Hybrid Modalities
Core
Champion the Product Quality organization for hybrid modality programs (e.g., ADCs), providing technical expertise and strategic leadership to ensure product quality from development through commercial lifecycle.
Role type
Senior IC Product Quality Director (Hybrid Modalities)
Builds
Pivotal and commercial product molecules (large/small molecule, bioconjugates) for patients with serious illnesses
Domain
Biopharmaceuticals / Biotechnology / Oncology / Inflammation / Rare Disease
Required skills
cGMP compliance, regulatory filing expertise, risk assessment, stability program management, cross-functional leadership, scientific oversight of comparability and specifications
Preferred skills
Bioconjugate development, analytical testing, project management, non-conformance investigation, matrix environment experience
Technologies
GMP systems, analytical techniques for small molecule and protein QC
Responsibilities
Lead Product Quality Team (PQT) and oversee stability programs; Provide scientific oversight for pivotal/commercial products including GMP document ownership; Execute regulatory filing sections and support audits; Manage complex long-term deliverables for hybrid modality programs; Mentor team members to develop core Product Quality skills
Seniority
Senior, hands-on IC with indirect staff management