Synthetics Principal Product Quality Leader
Core
Provide technical expertise and product leadership for synthetic pharmaceutical programs, ensuring quality from development through commercialization.
Role type
Principal Product Quality Leader (Synthetics)
Builds
Synthetic drug products (peptides, siRNA, extended release formulations) for patients with serious illnesses
Domain
Biopharmaceuticals / Synthetic Chemistry / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, regulatory documentation authoring, product quality risk assessment, comparability assessments, annual product reviews, cross-functional quality leadership, complex data evaluation, oral and written communication of technical information
Preferred skills
Chemistry or biochemistry degree, experience with synthetic modalities (peptides, siRNA), project management in pharma, non-conformance investigation support, understanding of bulk and drug product development
Technologies
GMP systems, data management systems, regulatory filing platforms
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; communicate quality strategies to leadership and regulatory agencies
Seniority
Principal, hands-on IC with strategic oversight
