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The Senior Human Resources Generalist provides HR process, administrative, and project support to the assigned site and/or business unit. Performs various human resources duties in areas such as employee engagement, onboarding, performance management, compliance, and employee relations, while supporting recruitment and HR administration.
We are seeking a LIMS Specialist to join our GMP-regulated laboratory environment. The ideal candidate will manage day-to-day LIMS operations, lead and execute GMP validation and computerized system validation (CSV) activities, support system configuration and integration, and perform hands-on development where required. Strong French and English communication skills and adherence to regulated quality standards are essential.
The Quality Assurance Specialist will be responsible for reviewing Operation and Analytical Chemistry department data, reports, protocols, and batch records. Perform release of raw materials, packaging materials, intermediates, and APIs. Maintain tracking and trending of investigations and compliance documents. Interact with cross-functional groups such as R&D, Analytical Chemistry, and Operations to ensure that quality standards and documentation are reviewed in a timely manner, and all standard operating procedures (SOP’s) are followed.
This position will be part of DP engineering team under WuXI STA, the role will design, develop, optimize and maintain as system owner the manufacturing automation system at Middletown, Delaware site. This may include systems on building automation, process automation and other digital systems through pharmaceutical drug products manufacturing and packaging platforms. The Engineer is also responsible for ensuring external and internal quality standards are applied and followed.
Reporting to the QC Analytical Lead, the QC Analyst will perform routine and non-routine analytical laboratory activities in support of drug product manufacturing at WuXi STA’s Middletown, DE site. This role includes analytical testing, stability sample handling, equipment operation, and documentation in accordance with GMP, corporate quality standards, and regulatory requirements. The QC Analyst will support both startup and steady-state operations, ensuring timely and accurate completion of QC tasks for product release, stability studies, and validation activities.
This position will be part of DP engineering team under WuXI STA, The role will design, develop, optimize and manage execution the whole lifecycle activities of GMP drug product manufacturing and packaging process including equipment 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.
Company Overview
WuXi STA Breaks Ground for New Pharmaceutical Manufacturing Facility in Middletown, Delaware | WuXi STA
About WuXi AppTec | Global CRDMO Leader Enabling Healthcare Innovation Worldwide
Job Summary
The Quality Specialist will work closely with operations and manufacturing...
STA Pharmaceuticals is constructing a new Greenfield CDMO facility to manufacture finished drug products in Middletown, Delaware.
To manage deliver the manufacturing system engineering, construction, CQV activities, start-up and operation of the new facility, we are seeking an experienced senior level of engineering lead 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 closely with executives to strategize and develop long-term plans that usher in new levels of productivity and success at STA Pharmaceuticals.
We are seeking a skilled and experienced Equipment Maintenance & Reliability Engineer to support 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 support the cGMP Maintenance & Controls Manager and the Utilities Superintendent to implement cGMP compliant preventive/predictive maintenance programs,...
Company Overview
WuXi STA Breaks Ground for New Pharmaceutical Manufacturing Facility in Middletown, Delaware | WuXi STA
About WuXi AppTec | Global CRDMO Leader Enabling Healthcare Innovation Worldwide
Reporting to the QC Microbiology Lead, the QC Analyst will perform routine and non-routine microbiological laboratory activities in support of drug product manufacturing at WuXi STA’s Middletown, DE site. This role includes microbiological testing, environmental monitoring, stability sample handling, equipment operation, and documentation in accordance with GMP, corporate quality standards, and regulatory requirements. The QC Analyst will support both startup and steady-state operations, working closely with the QC Microbiology Lead to ensure timely and accurate completion of QC tasks for product release, stability studies, and validation activities.
Operator I supports cGMP pharmaceutical manufacturing activities by executing batch operations, cleaning and setup, in-process checks, and documentation with a strong focus on safety, quality, and right-first-time performance. This role is fully trained to operate designated equipment and to work effectively within a cross-functional team in a regulated environment.
STA Pharmaceuticals, a WuXi AppTec Company, has an exciting opportunity for a Process Research and Development Scientist in our San Diego site.
This position works within a team of Process Research and Development (R&D) Scientists in conjunction with the Analytical Chemistry Department and is co-responsible for developing safe, efficient and easily scalable processes for producing starting materials, intermediates and active pharmaceutical ingredients (APIs). In addition, this position assists in tech transferring projects to Kilo Lab and Pilot Plant scales and contributes to the safe and cGMP compliant execution of API manufacturing processes.
WuXi AppTec is a trusted partner and contributor to the pharmaceutical and life sciences industries, providing R&D and manufacturing services that help advance healthcare innovation. With operations across Asia, Europe, and North America, we offer integrated, end-to-end services through our unique CRDMO (Contract Research, Development, and Manufacturing Organization) platform.
Guided by our vision that every drug can be made and every disease can be treated, we are committed to advancing breakthroughs for patients—one collaboration at a time. Learn more at
WuXi AppTec is a trusted partner and contributor to the pharmaceutical and life sciences industries, providing R&D and manufacturing services that help advance healthcare innovation. With operations across Asia, Europe, and North America, we offer integrated, end-to-end services through our unique CRDMO (Contract Research, Development, and Manufacturing Organization) platform.
Guided by our vision that every drug can be made and every disease can be treated, we are committed to advancing breakthroughs for patients—one collaboration at a time. Learn more at
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...
WuXi AppTec is a trusted partner and contributor to the pharmaceutical and life sciences industries, providing R&D and manufacturing services that help advance healthcare innovation. With operations across Asia, Europe, and North America, we offer integrated, end-to-end services through our unique CRDMO (Contract Research, Development, and Manufacturing Organization) platform.
Guided by our vision that every drug can be made and every disease can be treated, we are committed to advancing breakthroughs for patients—one collaboration at a time. Learn more at
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.
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...