HD Biosciences-US, a WuXi AppTec Company, is seeking an experienced and dynamic Senior Project Manager to coordinate and lead project management team and support business development activities. This role will collaborate closely with the internal scientific leaders, the business development team and clients to propose research service quotations, manage client relationships and project workflows, collect and analyze business data, and contribute to the company’s business development and strategic planning. The ideal candidate will also work alongside senior management, R&D group leaders, BD, legal, finance, marketing, and logistics teams to provide comprehensive project and business management and ensure high-quality research services to the clients.

This position is responsible to perform all type of analytical testing that is required for release of packaging materials and all the environmental sampling. The position is responsible for the documentation management for the QC Laboratory, the sample management and the management of the consumable (Reagent & others) by purchasing, receptioning and providing the Couvet Laboratory in time with materials. The management of the standards for the analytical testing is under the responsibility of this position. Additional responsibilities can be the support of the analytical testing, handling of deviations and change controls likewise the follow up and performs of complaints.

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).

STA is constructing new facilities to manufacture small molecule drug products. This will include capabilities for oral solid as well as sterile dosage forms manufacturing. As well as the supporting analytical, warehousing and other needed capabilities. The position will initially lead the team (including consultancy firms) responsible for the quality and compliance support during design, construction and qualification phases of these facilities. And will be responsible for the implementation of the quality system. After start of operations and manufacturing, this position will take...

The Training Associate II will have the responsibility for performing a variety of tasks related to learning and development in a Good Manufacturing Practices (GMPs) facility. The position requires providing classroom and laboratory training to site employees who produce and/or support Master and Working Cell Banks. The ideal candidate will have strong communication and leadership skills. The individual must be able to coach and mentor trainees and elevate issues to proper personnel timely.  

Responsible for building and supervising a team of manufacturing trainers and training coordinator(s) who coordinate, schedule, design, provide, document, maintain and improve training for all manufacturing personnel on matters including but not limited to: new hire orientation, department and facility specific training.

 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.   

Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO). We offer technology platforms and services that enable the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support patients around the world. Working at Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning. Our benefits...

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 Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.

The Human Resources Director is Responsible for providing the Human Resources support for assigned business groups and others as needed. Maintain relationships by being a true Senior Human Resources Business Partner with all levels of management. Provide HR support, recommendations and guidance, focused on employee engagement, performance management, head count and employee relations.  Collaboration with business leadership and US HR team members, leading HR projects in performance management, process improvement, learning & Development, investigations and ability to identify organizational gaps. Strong experience in MS office especially with Excel is a plus.   ** This is an...

Responsible for providing 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...

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  Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning....

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.

The Quality Control laboratory at the Couvet site performs analytical & microbiological testing of incoming materials, packaging components, in-process testing, drug product & drug substance release testing and stability testing. Multiple method transfers and validations are performed to support new products. This position is responsible for the Quality Control support activities, including the setup and maintenance of master data within LIMS, Empower and analytical instruments, setup and qualification of new instruments, audit trail review, and adherence with data integrity principles. As a QC leader, you will be customer focused. Using your significant experience, you will mentor and coach your team, creating a strong team...

LTD is seeking a strategic EU Market Director, International Marketing to drive awareness, thought leadership, and lead generation for our Drug Metabolism and Pharmacokinetics (DMPK), Toxicology, and Bioanalytical services in the European market. This role requires expertise in regional market trends, strategic content development, and performance-based marketing initiatives to support our EU business development team. The ideal candidate will collaborate with product managers, marketing leadership, subject matter experts (SMEs), and agency partners to execute impactful marketing campaigns that resonate with regional audiences.  

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. 

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

Performs any basic to complex Cell Potency and 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...

Coordinates and conducts maintenance and repairs of company equipment and the building; proactively addresses areas of concern to minimize unplanned downtime, increases equipment efficiency, and maintains a clean, safe work environment.

Associate Director, Project Management (Oligo and Peptide) Area of focus: Discovery or medicinal chemistry Job Location: Remote USA with 10% travel within USA or to China   WuXi TIDES, a leading Contract Research and Development Manufacturing Organization (CRDMO), is an integral part of the...