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 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 QC / Environmental operations, which includes implementing and maintaining appropriate environmental sampling and microbiology testing systems; supervising, training and evaluating personnel; analyzing and interpreting monitoring results; and making appropriate decisions and recommendations to address trends, issues or significant observations. Demonstrates leadership in a fast-paced manufacturing setting and operates with minimal oversight and a clear understanding of business and regulatory demands. Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of...

Responsible for duties associated with two or more Quality System processes, including: the administration, reporting and process creation / optimization / automation, while ensuring accordance with current good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP) and current Good Tissue Practices (cGTP). The processes comprising the Quality Systems include: Non- conformance / Investigations, CAPA, Change Control, Customer Audits, Supplier Audits, Training, and Supplier Qualification Program. Duties include effectively interacting with Testing, Manufacturing, Project Management and Quality Assurance personnel in order to deliver...

Main function is to release raw materials intended for Manufacturing and Testing Operations according to site policies and procedures. Assists in the preparation of Standard Operating Procedures (SOPs). Review and approve deviations and low-risk non-conforming events (NCEs). Lead and implement continuous improvement.

Responsible for providing technical support to the 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).

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.  

Designs, supervise, and interprets research & development and GMP studies.  Provides appropriate resources to team to conduct studies.  Supervises team of scientific personnel with varying skill level.  Directs and leads team to stay on track to meet project deadlines.  Oversees assay transfers between Technical Development and Testing Operations.  Serves as analytical lead on manufacturing core teams for low complexity programs.  Interfaces with Sales team regularly.  Authors technical documents, procedures, policies, SOPs, & risk assessments, as needed

Responsible for the support activities and disinfection of GMP space, equipment and associated areas involved in the manufacture of Master and Working Cell Banks, within production facilities involved in the manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsible for the support activities and disinfection of GMP space, equipment and associated areas involved in the manufacture of Master and Working Cell Banks, within production facilities involved in the manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsible for the support activities and disinfection of GMP space, equipment and associated areas involved in the manufacture of Master and Working Cell Banks, within production facilities involved in the manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsible for the support activities and disinfection of GMP space, equipment and associated areas involved in the manufacture of Master and Working Cell Banks, within production facilities involved in the manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

The Sample Coordinator will process incoming samples, assist with administrative duties relating to Central Sample Repository functions.

Introduction to Metrology and the scientific study of measurement. Metrology Technician I acquires training and the skills required for calibration of instrumentation & equipment. Metrology Technician I is introduced to the industry regulatory requirements and guidelines necessary for processing and creating documents. This individual will obtain detailed instruction and document all results consistent with all applicable quality standards and GXP requirements.  

Job Summary:   Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. As part of an inter-departmental team environment, collaborate with subject matter experts to resolve any Quality issues or improvements for new and existing clients, including being the QA single point of contacts for clients. Review and approve manufacturing batch records, non-conformances, deviations, and CAPAs in accordance with cGMP. Prepare Certificate of Analysis for batch release.      

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.   

Responsible for providing construction, engineering oversight and maintenance services for a state-of-the-art, multi-product contract manufacturing and testing facility. General responsibilities include: developing operational requirements for equipment/systems, developing request for proposals (RFP’s) for Facilities’ projects and supervise overall corrective and preventative maintenance program for facility, equipment and systems to support operations. Specific responsibilities include: maintaining and operating mechanical and utility systems, troubleshooting equipment/processes, ensuring regulatory compliance, and supervising internal facilities technician staff, external contractors and writing reports.

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).