STA Pharmaceuticals is constructing a new Greenfield CDMO facility to manufacture finished drug products in Middletown, Delaware. To support the detailed design, construction, CQV activities, and start-up of the new facility, we are seeking an experienced Director of Engineering to join our highly skilled team. As an ideal candidate, you will have proven senior management experience in a highly dynamic setting. Your organizational, communication, and leadership skills will help us develop solutions that push innovative boundaries. You will work...

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

In this position the Senior Specialist, Master Planning will manage within a mid and long-term scope the Supply Chain activities for the manufacturing site of Couvet. This position will be lead in close collaboration with key users working in Manufacturing Operations Services and other internal stakeholders (Quality Control, Quality Assurance, Validation, Maintenance, Production, Scheduling, ...). The Senior Specialist, Master Planning could act as backup of the Customer Service...

The Quality Control (QC) laboratory at the site of STA Pharmaceutical Switzerland SA performs analytical and microbiological testing of incoming materials, packaging components, in-process samples, drug products, drug substances, and stability studies. This position is responsible for performing all Super User activities for the QC laboratory computerized systems. This includes at least Audit Trail Reviews...

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...

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.

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.