Job Summary: We are seeking an accomplished and strategic Quality Control (QC) leader to establish and oversee all QC operations for WuXi STA’s new DE site. The QC Director will lead all Quality Control functions for WuXi STA's new drug product manufacturing site, including QC Analytical, QC Microbiology, and QC Operations. This role is responsible for establishing and maintaining GMP-compliant laboratory operations to support the release and stability testing of drug products, raw materials, and packaging components, as well as providing QC support for process and cleaning validation activities. During site startup, the QC Director will oversee lab buildout, equipment qualification, method transfers, staff recruitment, and quality system implementation. In...

We are seeking a skilled and experienced Utilities Superintendent to oversee the operation, maintenance, and reliability of all utilities, facilities, and grounds for our pharmaceutical manufacturing facility in Middletown DE. This role is responsible for ensuring all utilities equipment, automation & controls, and facilities are operated efficiently, safely, and maintained in compliance with Good Engineering Practices. The ideal candidate will lead a team of multi-skilled operators and maintenance technicians, manage vendor service contracts, and implement preventive/predictive maintenance programs, while working closely with cross-functional teams to...

This role will design, develop, optimize, and support GMP drug product manufacturing and packaging process, including equipment, facilities, and control systems at our Middletown, Delaware site. This may include support of CQV programs for manufacturing/packaging equipment, instruments, utilities, and processes. The Engineer is also responsible for ensuring external and internal quality standards are applied and followed.

Le Technician Bulk Operations aura pour mission d’assurer les activités de fabrication des produits (capsules ou comprimés), dans le respect de la réglementation BPF / cGMPs, des règles d’hygiène, et de sécurité. Il devra se conformer aux procédures définies par le système qualité du site pharmaceutique.