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.   

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.

L'Operator I Packaging Operations aura pour mission d'assurer les activites de conditionnement des produits (blister, bouteille, etui, wallet, inspection visuelle), dans le respect de la reglementation BPF / cGMPs, des regles d'hygiene, et de securite. II devra se conformer aux procedures definies par le systeme qualite du site pharmaceutique.

WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Quality Department for an Associate Compliance Analyst.   Shift is Tuesday - Saturday

Manager, Business Development drives sales growth in close coordination with WuXi Biology leadership. Business Development Manager will have an additional focus on penetrating certain assigned customers with significant growth opportunity, as assigned by management. Business Development Manager’s most important means of interacting with customers and prospects is through face-to-face meetings and is responsible for achieving an assigned sales goal. The role may involve providing project management support to key clients in order to develop a stronger business relationship and broaden the scope of interactions with the client.

The Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. He/she supports the Head of Bulk and/ or Packaging Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation and training. He/she is the manufacturing referee for the batch record creation and revision in PAS-X electronic system.

HD Biosciences Inc. a WuXi AppTec company, is a fast growth, fast paced biology-focused preclinical drug discovery contract research organization (CRO). 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 I or Scientist II to perform Liquid Chromatography Mass Spectrometry (LCMS) bioanalysis studies.

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.   

WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Media Prep department for an Associate Sterilization Technician.  This position will work to prepare various media in compliance with GLP, GMP and ISO standards.   Tuesday - Saturday.     This is a full-time, permanent position offering comprehensive employee benefits. Starting pay for this role is $17/hr.

The primary responsibilities of this position will be to lead database or statistical programming activities and provide end to end programming support in planning, specifying, designing, developing, and implementing solutions for the clinical trials in accordance with applicable processes. Provide extensive technical expertise as part of the Database and Statistical Programming (DSP) team to develop, test, maintain, validate, and document programs to...

Responsible for administering Document Control processes, including: issuance, tracking, implementation, obsoletion, and archival of all controlled document types, while ensuring accordance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) for Laboratory Studies.

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. 

Lead and manage process equipment introduction and process improvements to increase the capability and capacity of WuXi ATU in cell and gene therapies. Apply process engineering principles and GMP knowledge in manufacturing of Advanced Therapy Medicinal Products (ATMPs) to improve and troubleshoot current processes. Directly responsible for meeting user requirements and project schedule for project delivery from feasibility through commissioning/qualification, and hand over to the end users. Coordinate with other functional groups such as EHS, QA, Manufacturing, Testing Operations, Process Development, Facilities, Metrology, Validation, and IT for project delivery. Directly responsible for tracking cost, schedule, targets and achievements.

This position is a key leadership role being responsible for the direct management of individual contributors, supervisors and managers.   This position is a role model for the WuXi values and competencies.   Job Summary:  

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.

The primary responsibilities of this position are to lead study level statistical related activities, particularly to write statistical analysis plans, prepare mock tables/figures/listings, and generate statistical analyses for clinical studies.

Primary resource for the development, execution, review, and approval of equipment/software validations (including Computerized Laboratory Systems), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change Controls, Decommissioning Reports, etc., in accordance with 21 CFR Part 11 and GAMP5. Monitors equipment/software processes for adherence to established procedures/regulatory compliance. Provides guidance for equipment/software related issues and consults with QA Management to resolve complex quality issues in a timely manner.

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.