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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).
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).
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.
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.
Responsible for the human resources strategy and support for assigned business unit. Maintain relationships by being a strategic partner with management. Provide HR recommendations and guidance, manage performance management processes, and resolve employee relations issues. Manage and supervise site HR staff.
The sample receiving manager oversees the sample receiving group which is responsible for the receipt, verification, storage, and chain of custody of all samples received/shipped out of the facility.
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.
With supervision serve as study director/principal investigator to perform MD, MV/MQ and Sample analysis for Large Molecule (LM) Bioanalysis projects. Troubleshoots Wet Lab LM Bioanalysis assays issues and assist in training of LM analysts on wet lab LM systems. Can communicate; write responses to QC/QA findings. Communicate with Clients on specific projects that they are responsible. Accountable for accurate data submission and on time delivery of assigned projects.
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.
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.
The anticipated schedule for this position is Tuesday - Friday (8:00 AM - 5:00 PM) & Saturday (6:30 AM - 2:30 PM). New employees will be expected to start out on a Mon-Fri schedule for training prior to transitioning to their permanent schedule.
This is a full-time, permanent position offering comprehensive employee benefits. Starting pay for this role is $17/hr.
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 compliance and maintain quality standards.
The Human Resources Information Systems (HRIS) & Data Analyst provides technical and analytical support to the Human Resources department in pursuit of HRIS initiatives and other HRIS-related responsibilities. This includes but is not limited to maintaining quality and consistency of HRIS database information; ensuring personnel actions are following current Human Resources policies and guidelines; providing HRIS technical support to Human Resources and other staff; serving as liaison to other functional areas such as Benefits, Human Resources, Recruiting, Payroll and Finance. Supports methods to measure effectiveness of people programs, uncover insights and opportunities; and build capacity within the People organization to utilize data and analytics to drive decision-making.
This is a mostly remote position, working in-person one day per week at either the Cranbury, NJ or Philadelphia Navy Yard facility.
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.
With over 1,000 scientists from 9 R&D and manufacturing sites, we offer discovery compound screening and synthesis, process development and manufacturing of novel monomers, linkers and ligands, oligonucleotides, peptides and complex synthetic conjugates at any scale. Beyond chemistry, we offer formulation development, drug product manufacturing, labeling and distribution services in a variety of injectable dosage forms and filling formats including the Lipid Nanoparticle (LNP) drug delivery platform. Our comprehensive analytical method development, validation and testing platform will support your needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC dossiers to support global filings for TIDES new drug applications.
Job Summary: The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for STA Pharmaceutical, a WuXi AppTec company, in particular to support the growth of emerging Discovery oligonucleotide and peptide (O&P) Contract Development and Manufacture (CDMO) business. The candidate will work closely together with the U.S business development (BD) teams to pursue new business leads; follows up on critical issues and aides in resolving customer inquiries. Assists marketing in delivering content and driving success of new and existing services. This position will report to the Director of Business Development, Oligo/Peptide and will help to support Discovery O&P BD efforts.
WuXi Clinical, a full service CRO, is hiring a Senior Study Start-Up Specialist. The Senior Study Start-Up Specialist provides supervision to Study Start Up Specialists at the discretion of the Manager. Provides study start-up guidance and training oversight in support of WuXi Clinical Development (WXC)Clinical teams. Ensures the contracted services and expectations of the Sponsor are carried out in accordance with the executed contracts. Supports Line Manager with evaluation and implementation for process development to support efficiency and quality performance.