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The primary responsibilities of this position are to provide leadership in planning and conducting data analyses in clinical studies, and participate in planning and data analyses for regulatory submission.
WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.
Working at WuXi Advanced...
WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.
Responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).
Responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).
Responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).
The QA Specialist I will provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. High level job accountabilities included activities related to sterility assurance, manufacturing oversight, quality system and release of raw materials.
Hours: 12 PM to 10 PM
Schedule: Sun-Wed or Wed-Sat
Location: 100% In-person at our Philadelphia site
WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.
WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.
Working at WuXi Advanced...
WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.
WuXi Advanced Therapiesis a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.
Sufficient scientific training and competence to perform basic complexity Flow Cytometry and/or Cell Based Assays according to, and in compliance with, current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). As part of standard work, completes assigned Test Methods and other required documentation and general laboratory duties according to relevant cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision. The ideal candidate will have basic flow cytometry theory and/or instrumentation and complete site training in flow cytometry assays using 1-4 colors. Experience in mammalian cell culture is desirable but not a...
Job Locations: Shanghai/Nanjing, China
Department: Drug Metabolism and Pharmacokinetics (DMPK) Service Department
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.
WuXi AppTec's Medical Device Testing business, has operating entities in both the United States and China. This division provides an integrated testing platform for medical devices which includes biocompatibility testing, chemical characterization, toxicological risk assessment, biological evaluation, large animal studies, microbiological testing, etc. The testing platform has established its China Medical Device Testing Center in Suzhou Wuzhong District with international FDA GLP, OECD GLP, CNAS, ISO13485, A2LA quality management standards and Chinese CMA and AAALAC operational standards, comprising of the outstanding International technical and management teams. At the...
WuXi Chemistry, a business division of WuXi AppTec, provides contract services for new drug development from discovery to commercial. Our unique CRDMO model offers an integrated solution combining traditional CRO (contract research organization), CDMO (contract development and manufacturing organization) and CMO (contract manufacturing organization) services under one roof.
As a world leading chemistry service organization, WuXi Chemistry have over 18,000 employees from our 15 research, development or manufacturing sites worldwide, serving over 1,800 clients from top pharma to virtual biotech companies....
The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality control functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and WuXi Clinical Standard Operating Procedures (SOPs). This is an office or remote based position and requires approximately 50-75% travel.
Job Locations: Suzhou, China
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services,...
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products...
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products...