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The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for WuXi Tides and STA Pharmaceutical, a WuXi AppTec company, in particular to support the growth of emerging oligo and peptide (O&P) Contract Development and Manufacture (CDMO) business. The candidate will work within the US business development (BD) team to pursue new business leads; follows up on critical issues and aid in resolving customer inquiries. Assists marketing in raising the profile of WuXi Tides within Europe.
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.
The Senior Manager, Business Development for the EU recruits customers, and drives sales growth of products and services. The Senior Manager, Business Development will have an additional focus on penetrating certain assigned customers with significant growth opportunity, as assigned by management. Reporting to the Executive Director of Business Development, the BD closes and implements growth opportunities with Companies in Scandinavia and other territories if assigned. The BD’s most important means of interacting with customers and prospects is through...
(Senior) Director of Quality Assurance (STA Qualified Person (QP))
Location: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site.
QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products.
This position is responsible for quality assurance (QA) involved primarily with the review of bulk or packaged commercial drug products, raw material batches if required and maintaining working relationships with QA departments at contract facilities. The position will support on the floor QA activities (deviation, CAPA, OOS, change control, batch release, archiving, complaints …) Couvet site included work in 2*8 shift if...
This position is accountable for all New Product Introductions at the site of Couvet, Switzerland. This includes leading the Manufacturing, Science and Technology, MS&T team. The site is currently expanding its capabilities and capacities, and there are future expansions planned.
Your strong technical knowledge and experience of transferring late clinical stage and commercial OSD projects will help you successfully oversee multiple projects in parallel.
After training has been completed on 1st shift, the supervisor will work the following:
Quad 4: (Thurs – Sat, Alternating Wednesdays, 12hr Shifts, 2 pm - 2:30 am)
Job Summary:
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.
The primary responsibilities of this position are to provide statistical consulting to clients in the biotech/pharmaceutical industry in their drug development programs with a focus on protocol/study design, analysis planning, and regulatory submission strategies.
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.
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
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.