Senior Specialist, Sterile Drug Product, QA Manufacturing Operations Manufacturing
Core
QA oversight for the start-up and commercial operations of a sterile biologics manufacturing facility, ensuring compliance with cGMP during construction, validation, and production.
Role type
Senior Specialist, QA Manufacturing Operations (Sterile Drug Product)
Builds
Commercial sterile drug product manufacturing lines (formulation, aseptic filling, lyophilization, capping, AVI) and associated quality systems.
Domain
Biopharmaceuticals / Sterile Drug Manufacturing
Required skills
cGMP compliance, Sterile Drug Product knowledge, Batch record review, Change control assessment, CAPA evaluation, GMP reviews, Operational Excellence (5S, Kaizen), Audit support, SOP development, Training program execution
Preferred skills
Aseptic filling, Lyophilization, Visual Inspection, MES implementation, Tech Transfer support
Technologies
MES, MBR, CQV systems
Responsibilities
Provide QA oversight for aseptic sterile drug product processes; Review and approve batch records and functional area documentation; Support CQV, Tech Transfer, and Operational Readiness activities; Author and review QA-related procedures; Support internal and external audits; Drive continuous improvement initiatives.
Seniority
Senior, hands-on IC