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 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.

Responsible for providing supervision in the cleaning and sanitization of GMP space and associated areas that manufacture Master and Working Cell Banks, within production facilities that manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).   This is a night shift opportunity.  The hours are 4:00pm - 2:30am.  

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 training staff on Good Documentation Practices (GDP), Good Laboratory Practices (GLP), aseptic techniques, basic and advanced laboratory skills, as well as, supporting EHS compliance and risk management within the Atlanta facilities. The EHS representative will monitor and coordinate processes to prevent and eliminate injury and illness to employees and assist the company to comply with safety regulations.

Performs any basic to complex Analytical assay(s) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Completes Test Methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision. Sufficiently competent in science to initiate and carry out scientific development projects related to the development of new assays, initiation of new programs, assay validations and associated projects. Performs and thoroughly documents Research & Development activities...

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

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 US. 

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

HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its in vivo Pharmacology team. We’re seeking a highly skilled and motivated Research Associate III to support our in vivo pharmacology team for various projects.

WuXi AppTec Pathologists contribute to a wide range of critical activities within Toxicology, Safety, and Biocompatibility. Testing including but not limited to study evaluation for nonclinical studies spanning all phases of drug development for pharmaceutical industries.   This is a remote/work from home position in US.

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.

Scientists (San Diego, CA) – Develop and modify efficient and safe scalable processes for producing pharmaceutical starting materials, intermediates, and APIs; Apply pharmaceutical process (dissolution, mixing and crystallization, etc.), pharmaceutical industrial engineering knowledge (pharmaceutical design, development, manufacturing, and regulatory requirements) to optimize technical transfer from lab-scale to kilo lab/pilot plant production; Implement hazard operability analysis and risk assessment skills to draft batch records and safety reports; Analyze lab and production data using NMR instrumentation, data interpretation, Chromatography to ensure FDA regulatory...

WuXi TIDES, a leading Contract Research and Development Manufacturing Organization (CRDMO), is an integral part of the WuXi AppTec’s subsidiary WuXi STA. WuXi TIDES offers our worldwide partners efficient, flexible, and high-quality solutions for the drug development of oligonucleotides, peptides and related synthetic conjugates (“TIDES” drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof.  

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. 

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...

Execute Business Development plans in close coordination with Research Chemistry Service (RCS) leadership leading to identification, penetration and growth of business and accounts in UK/Ireland region. The (Senior) Director Business Development UK drives sales growth in close coordination with Research Chemistry Services leadership penetrating certain assigned customers with significant growth opportunity, as assigned by management. Reporting to the Executive Director, Business Development, the (Senior) Director Business Development closes and implements growth opportunities with...

(Senior) Director of Quality Assurance (STA Qualified Person (QP))   Location: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site.