This position is accountable for the overall Quality Control activities at the drug product manufacturing site of Couvet, Switzerland, including but not limited to method transfer / verification / validation, release of incoming materials and packaging components, in-process testing and release of drug product, stability study, as well as support of the manufacturing related area operation such as environment monitoring.  You will ensure activities meet cGMP requirements and customers’ expectations.   As the QC head, you will be focused on the customers’ needs and execution...

We are seeking a QC Operation Specialist to provide critical operational support to the QC laboratories at WuXi STA’s Middletown, DE site. This role is responsible for stability room and equipment management, sample logistics, and controlled documentation, ensuring QC laboratories operate efficiently, meet testing timelines, and remain in full compliance with GMP and regulatory requirements. The QC Operation Specialist will be a key contributor during both startup and steady-state operations, supporting Analytical and Microbiology QC teams.  

Reporting to the QC Microbiology Lead, the QC Microbiology Scientist will perform advanced microbiological laboratory activities in support of drug product manufacturing at WuXi STA’s Middletown, DE site. This role includes execution and troubleshooting of microbiological testing, environmental monitoring, stability sample handling, equipment operation, method transfers, and documentation in accordance with GMP, corporate quality standards, and regulatory requirements. The QC Microbiology Scientist will support both startup and steady-state operations, ensuring timely and accurate completion of QC tasks for product release, stability studies, validation, and regulatory audits.    

Reporting to the QC Analytical Lead, the QC Analytical Scientist will serve as a technical expert in analytical chemistry testing and laboratory operations in support of drug product manufacturing at WuXi STA’s Middletown, DE site. This role includes advanced execution and troubleshooting of analytical methods, stability studies, method transfers, and equipment qualification, as well as maintaining compliance with GMP, corporate quality standards, and global regulatory requirements. The QC Analytical Scientist will play a critical role in both startup and steady-state operations, ensuring timely and accurate testing for product release, validation, and regulatory inspections.  

The QC Microbiology Lead will manage all microbiology laboratory activities at WuXi STA’s drug product manufacturing site in Middletown, DE. This role is responsible for establishing, maintaining, and continuously improving GMP-compliant microbiological testing programs for drug product manufacturing, including environmental monitoring (EM), water system monitoring, bioburden, endotoxin, and identification testing. The QC Microbiology Lead will play a key role in site startup by building the micro lab infrastructure, qualifying equipment, and establishing EM programs. In steady-state operations, this role will ensure timely execution of microbiology testing to support manufacturing, product release, cleaning validation, and regulatory readiness.

The QC Analytical Lead is responsible for establishing and managing all analytical operations for the QC function at WuXi STA’s new drug product manufacturing site in Middletown, DE. This role will oversee laboratory build-out during site startup, including equipment procurement and qualification, method transfers from global R&D and client facilities, and the implementation of GMP-compliant systems for testing drug products, raw materials, and components. The QC Analytical Lead will ensure timely and accurate execution of release and stability testing to support manufacturing and packaging operations, and will provide analytical support for process validation, cleaning validation, and packaging verification. This position serves as the subject matter...

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 Equipment & Controls Maintenance Manager to oversee the maintenance, repair, and reliability of base building and manufacturing equipment in our pharmaceutical manufacturing facility. This role is responsible for ensuring all equipment, automation & controls, utilities, and facilities are operated efficiently, safely, and maintained in compliance with Good Manufacturing Practices (GMP), FDA, and other regulatory standards. The ideal candidate will lead a team of multi-skilled maintenance technicians and engineers, implement preventive/predictive maintenance programs, while working closely with cross-functional teams to support production goals and continuous improvement initiatives.

L'Operator Bulk Operations aura pour mission d'assurer les activites de fabrication des produits (capsules et (ou) comprimes), dans le respect de la reglementation BPF / cGMPs, des regles d'hygiene, et de securite. II devra se conformer aux procedures definies par le systeme qualite du site pharmaceutique.

Job Summary:   The Validation Technician, performs validation and qualification activities. They assure compliance of these activities with cGMP as well as with internal policies and procedures. The Validation Technician is authorized to direct external vendors performing work in this field.