Principal Product Quality Leader (Synthetics)
Core
Provide technical expertise and product leadership for synthetic pharmaceutical products, ensuring quality from research through manufacturing and regulatory compliance.
Role type
Principal Product Quality Leader (Synthetics)
Builds
Synthetic pharmaceutical bulk and drug products
Domain
Biopharmaceuticals / Synthetic Modalities
Required skills
cGMP knowledge, regulatory document authoring, product quality risk assessment, comparability assessments, annual product reviews, cross-functional quality leadership, complex data evaluation
Preferred skills
Chemistry/Biochemistry degree, synthetic modality experience (peptides, siRNA), project management, non-conformance investigation, matrix environment experience
Technologies
GMP systems, data management systems
Responsibilities
Author and review GMP and regulatory documents; execute transactions in GMP systems (change control, data systems); manage product data including comparability and annual reviews; support late-phase and commercial synthetic programs; evaluate complex process and product quality data
Seniority
Principal, hands-on IC with strategy & mentorship
