Click column header to sort
Responsible for the day-to-day operation, maintenance, and repairs of the mechanical and utility systems associated with the STA San Diego and HDB facilities. This includes the building HVAC and chiller systems, house vacuum pumps, compressed air system, liquid nitrogen tank and distribution system, electrical system, boiler system, laboratory and Kilo Lab fume hoods, and associated utilities/equipment in the Pilot Plant. This may include performing maintenance/repairs as well as working with various external contractors and service providers.
HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its in vivo Pharmacology Division. We are seeking highly skilled and motivated Research Associate to join the team.
We are seeking a highly experienced and detail-oriented CQV (Commissioning, Qualification, and Validation) Lead Engineer 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.
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,...
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...
HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its in vivo Pharmacology team. We’re seeking a highly motivated Research Associate I to support our in vivo pharmacology team for various projects.
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 a fast-growing research and services division in WuXi AppTec and are working on developing cutting-edge multidisciplinary drug discovery platforms combining the latest technologies in biology, chemistry, biophysics, engineering, and informatics. We are seeking a highly motivated and collaborative biophysicist to play an integral role in expanding the capabilities at our site in Natick MA. This position is critical to the successful development, implementation and business operations of biophysics platforms...
We are a fast-growing research and services division in WuXi AppTec and are working on developing cutting-edge multidisciplinary drug discovery platforms combining the latest technologies in biology, chemistry, biophysics, engineering, and informatics. We are seeking a highly motivated and collaborative biophysicist to join us. This position is critical to the successful development, implementation and business operations of biophysics platforms and services for the business unit based in Natick, MA.
The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site’s quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas.
This position is a leadership role, being responsible for the direct management of people managers & individual contributors. As a key leader, you are jointly responsible for the site culture by leading by example and role modeling WuXi values and competencies.
Job Summary: Lead the material supply processes related to products manufactured at the Middletown site, from the procurement of the raw materials to the shipment of finished goods, as well as manufacturing master data management.
Overview
WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with worldwide operations. As an innovation-driven and customer-focused platform, WuXi AppTec provides a broad and integrated portfolio of services to help global customers and partners shorten the discovery and development timeline and reduce the cost of drug and medical device R&D through efficient and cost-effective solutions.
Within our Testing Division, we...
The Portfolio Manager plays a pivotal role in managing key accounts, fostering client relationships, and coordinating program workflows to drive the growth and expansion of our comprehensive drug discovery services. Responsible for the strategic oversight and management of the assigned portfolio of projects and programs. This role involves selecting, prioritizing and optimizing initiatives to align with the business goals, maximize return on investment (ROI) and manage risks. The Portfolio Manager collaborates with senior leadership, program managers, and project teams to ensure efficient resource allocation and delivery of strategic outcomes. They play a critical role in...
HD Biosciences Inc., a WuXi AppTec company, offers biology-focused preclinical drug discovery services to biotech and pharmaceuticals. We offer our clients comprehensive service platforms around target validation, plate-based pharmacology, hit identification and lead discovery, in vivo pharmacology, as well as other research and development services.
We are seeking a highly motivated and skilled scientist to support our neuroscience platforms to find cures for the neurodegenerative and neuroinflammatory diseases. The successful candidate will be responsible for developing and executing advanced vitro assays using human iPSC-derived neuronal cells, primary neuronal cells, co-culture systems, and other cellular models to support drug...
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...