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The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for STA Pharmaceutical, a WuXi AppTec company, in particularly to support the growth of the emerging Discovery oligonucleotide and peptide (TIDES) Contract Development and Manufacture (CDMO) business. The candidate will work closely together with the U.S. and Europe business development (BD) teams to pursue new business leads, follow up on critical issues and aides in resolving customer inquiries. Assists marketing in delivering...
The incumbent will lead a team to cultivate business relationships and opportunities to generate revenue with prospective and existing clients for WuXi TIDES, a WuXi AppTec company. In particular, to support the growth of the rapidly growing oligonucleotide and peptide (O&P) Contract Research, Development and Manufacture (CDMO) business. The candidate will work closely together with the Europe and global business development leaders to pursue new business leads, follow up on critical issues, and aid in attending to customer inquiries. Assists marketing in delivering content and driving the success of new and existing services.
We are seeking an experienced General Counsel to join our growing business in Europe. This role will support our expanding operations across Europe, ensuring compliance with applicable laws and regulations, managing privacy and data protection, advising on government and regulatory affairs, and providing support for employment, commercial, and operational matters.
The ideal candidate will bring strong legal expertise in the life sciences or biotech industry, be well-versed in EU and local regulatory frameworks, and possess excellent...
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.
The QC Manager is responsible for the integration of New Product Introductions (NPI) within QC. This role requires strong leadership,...
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...
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.
We are seeking a highly experienced and detail-oriented CQV (Commissioning, Qualification, and Validation) Manager to lead the execution of commissioning qualification, and validation activities at our pharmaceutical manufacturing facility. The CQV Lead Engineer is responsible for ensuring all equipment, computerized systems, facilities, and processes meet regulatory and quality standards (FDA, EMA, ICH) and are in a state of control throughout their lifecycle. The ideal candidate will manage cross-functional projects and work teams, interface with contractors and engineering teams, and drive compliant, efficient validation programs across both new and existing operations.
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.