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 position within the Validation department. You will be responsible for the qualification of IT systems and equipment. Working with the validation team, you will qualify IT infrastructure, software applications (MES, WMS, ERP, RMS, OSI PI, etc.) and their interfaces between each other and with equipment.  

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. 

This individual will be responsible for performing the daily husbandry aspects of all animals in compliance with GLP, USDA and AAALAC guidelines.  Please note the shift for this position is Tuesday-Saturday, 6:00am - 2:00pm. 

The Senior Metrology Technician assists the Manager in maintaining operational readiness of the company by meeting calibration, validation, and environmental requirements.   This is a full-time position with an anticipated schedule of standard business hours, Monday to Friday. 

The Director, Business Development -US East will expand Biology Division business in US as part of the broader Business Development team, through proactively managing the sales process, following up on leads, filling the pipeline to meet the yearly revenue targets for the region whilst demonstrating WuXi AppTec’s core values and complying with Company Policies. Leading and managing a team to achieve Division targets, provide exceptional customer service and to build capabilities in the region. Please note the location of this job is remote / work from home.  Overnight travel requirement is approximately 50%.

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).

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.