WuXi AppTec

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Search Results Page 3 of 13

Job Locations US-PA-Philadelphia
The Financial Analyst position is an integrated financial position with primary responsibilities over financial reporting and support department business partnering. This position will be a key contributor to assisting in consolidation of financial results, generation of sales & site financial reporting and performing reviews of site discretionary spend.
External ID
WXATU-3075
Job Locations US
STA is constructing a new Greenfield facility to manufacture small molecule active pharmaceutical ingredients (drug substances). In addition to small molecule active pharmaceutical ingredient manufacturing, this will include capabilities for oligonucleotides, peptides and High Potent drug substances.
External ID
WXSTA-11252
Job Locations US-PA-Philadelphia
Responsible for generating and/or review manufacturing related technical documents and manage timely closure of these documents. This includes but is not limited to Non-Conforming Event (NCE) investigations, CAPAs, Change Controls (CC), Batch Records (BR), Technical Transfers (TT), Final Reports (FR), and Standard Operating Procedures (SOP).
External ID
WXATU-3073
Job Locations US-PA-Philadelphia
Assists the Business Excellence Department with the Planning, Tracking and Reporting of Key Site Projects. Assists in the development, standardization and launching of Key PMO Tools and Methodology to the Business Excellence team and the PHL WuXi Site. Leads and oversees all project lifecycle efforts to develop and maintain project plans and timelines, communicate the project status reports to team members, project stakeholders, and management and escalate issues to insure prompt resolution. Responsible for overall assessment, planning, initiation, execution, monitoring and delivery of projects. Oversees the orderly progression of projects from proposal development through project completion by interacting with the project team and key project stakeholders.
External ID
WXATU-1765
Job Locations US-NJ-Cranbury
Primarily responsible for developing and executing Liquid Chromatography Mass Spectrometry (LCMS) analysis and/or HTS Screening assays, the scientist will work closely with a diverse team of scientists to facilitate all aspects of running a HTS laboratory. 
External ID
WXXBL-14725
Job Locations US-NJ-Cranbury
Primarily responsible for developing and executing Liquid Chromatography Mass Spectrometry (LCMS) analysis and/or HTS Screening assays, the scientist will work closely with a diverse team of scientists to facilitate all aspects of running a HTS laboratory. 
External ID
WXXBL-14724
Job Locations US-PA-Philadelphia
The Project Coordinator II supports project and commercial client activities, such as schedule generation, following up on internal actions and deliverables, and coordinating internal and external material or sample shipments so they can be received properly and in a timely manner.  Communicates and coordinates with all internal stakeholders with direct client interactions.  Develops a thorough understanding of the processes and systems associated with managing client activities, while gaining a foundational understanding of the technical aspects of a project / product.
External ID
WXATU-1846
Job Locations US-PA-Philadelphia
Responsible for coordinating the training for those who produce Master and Working Cell Banks and activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).
External ID
WXATU-3072
Job Locations US-MN-St. Paul
The IT Project Manager is responsible for leading multiple infrastructure and software projects along with internal technology enhancements. The individual is responsible for identifying, planning and managing all project milestones. This position supports internal customer deliverables across the entire US and Europe organizations.
External ID
WXLLC-12233
Job Locations US-MN-St. Paul
Who is WuXi AppTec? WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. Our St. Paul, Minnesota site is a rapidly growing global leader in the medical device (ranging from simple tongue depressors and adhesive bandages to complex programmable pacemakers) and combination product testing industries, focusing on nonclinical testing that includes biocompatibility, safety toxicology, and analytical chemistry.  Our teams support some of the most innovative medical devices and combination products created by leading medical device manufacturers both locally and globally. Our Test Facility plays a vital role in understanding the unique interface between biomedical engineering and the biology of living things.    As an innovative-driven, customer-focused organization, WuXi AppTec’s open-access platform enables global collaboration from over 30 countries to improve the health and/or treatment of patients in need, and to realize WuXi AppTec’s vision that “every drug can be made and every disease can be treated.”  For more information please go to http://us.wuxiapptec.com/.   WuXi AppTec Offers: Medical, Dental, and Eye care Coverage - Health Savings Account + Employer Contribution - Flexible Spending Account - 401(k) Savings Plan + Employer Match - Employer Paid Basic Term Life and AD&D Coverage Employer Paid Long Term Disability Insurance - Short Term Available with Employer Contribution Generous Personal Time Off Plan (PTO) + 10 Holidays Per Year   Department Description:  The Study Operations department is the center point of control for all studies conducted within the facility. Study operations in responsible for development and execution to the study protocol, client communication about individual study information and clarification, and reporting of final assay results. Clients may request an individual test for an individual medical device, but often requests a panel of tests to support FDA submission depending on medical device use. Tasks executed within the department can be placed into the following three categories in most cases. - Front end work tasks involving a study would be review of study information, initiation of the study, and client communication involving clarifications such as test article preparation instructions. Review of study information and request for clarification are completed at a panel level when available and appropriate. - On test work tasks involving a study would be providing instruction and support to laboratory staff as necessary, troubleshooting and client communication of unexpected or unusual observations, and leading or being involved in investigations observed during the study and study impact such as deviations or laboratory investigations. - Back end work tasks involving a study would be complete review of study data, determination of study validity and results, drafting and finalization final report, and engaging with Quality Assurance during report review process as required.   The Administrative role will support execution and completion tasks in a variety of ways.  Job Summary:  The Data Entry/Admin Assistant provides the administrative support to assist Study Specialists and Study Directors in their completion of nonclinical studies that meet WuXi AppTec’s Clients/Sponsors expectations.
External ID
WXINC-23425
Job Locations US-MN-St. Paul
Who is WuXi AppTec? WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. Our St. Paul, Minnesota site is a rapidly growing global leader in the medical device (ranging from simple tongue depressors and adhesive bandages to complex programmable pacemakers) and combination product testing industries, focusing on nonclinical testing that includes biocompatibility, safety toxicology, and analytical chemistry.  Our teams support some of the most innovative medical devices and combination products created by leading medical device manufacturers both locally and globally. Our Test Facility plays a vital role in understanding the unique interface between biomedical engineering and the biology of living things.    As an innovative-driven, customer-focused organization, WuXi AppTec’s open-access platform enables global collaboration from over 30 countries to improve the health and/or treatment of patients in need, and to realize WuXi AppTec’s vision that “every drug can be made and every disease can be treated.”  For more information please go to http://us.wuxiapptec.com/.   WuXi AppTec Offers: Medical, Dental, and Eyecare Coverage - Health Savings Account + Employer Contribution - Flexible Spending Account - 401(k) Savings Plan + Employer Match - Employer Paid Basic Term Life and AD&D Coverage Employer Paid Long Term Disability Insurance - Short Term Available with Employer Contribution Generous Personal Time Off Plan (PTO) + 10 Holidays Per Year   Department Description:  The Study Operations department is the center point of control for all studies conducted within the facility. Study operations in responsible for development and execution to the study protocol, client communication about individual study information and clarification, and reporting of final assay results. Clients may request an individual test for an individual medical device, but often requests a panel of tests to support FDA submission depending on medical device use. Tasks executed within the department can be placed into the following three categories in most cases. - Front end work tasks involving a study would be review of study information, initiation of the study, and client communication involving clarifications such as test article preparation instructions. Review of study information and request for clarification are completed at a panel level when available and appropriate. - On test work tasks involving a study would be providing instruction and support to laboratory staff as necessary, troubleshooting and client communication of unexpected or unusual observations, and leading or being involved in investigations observed during the study and study impact such as deviations or laboratory investigations. - Back end work tasks involving a study would be complete review of study data, determination of study validity and results, drafting and finalization final report, and engaging with Quality Assurance during report review process as required.  The Study Director role is responsible for executing and coordinating all tasks listed above on individual studies and is the single point of control throughout the lifecycle of the study. Job Summary: Responsible for all aspects of assigned standard biocompatibility studies performed within the In Vitro Testing Services (IVTS) department at WuXi AppTec in compliance with GLP, ISO, FDA, and any other applicable guidelines.  Interface between the St. Paul facility and the customer for study planning, organization, final report generation, and customer communication.
External ID
WXINC-22994
Job Locations US-GA-Marietta, Georgia
WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening for a Laboratory Supervisor.  The supervisor is responsible for all aspects of daily management of the Microbial Solutions laboratory.  Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining facility's standards.
External ID
WXINC-21570
Job Locations US-GA-Marietta, Georgia
WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening for a Technical Specialist.  The Technical Specialist will be responsible for providing to clients the expertise, consultation and technical guidance for validations and custom studies through the development of validation and test plans in one or more of the following areas: microbial / antimicrobial studies, sterilization validations, reusable medical device reprocessing and bacterial endotoxin tests.
External ID
WXINC-23036
Job Locations US-GA-Marietta, Georgia
WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening for an Equipment Validation Specialist.
External ID
WXINC-23360
Job Locations US-MN-St. Paul
This position is responsible for processing samples for assigned tests in compliance with GMP, ISO, and other standards including test sample log in and accountability.
External ID
WXINC-23417
Job Locations US-MN-St. Paul
The Database Administrator will be responsible for the performance, security and integrity of all company databases within our organization.  The DBA will provide technical expertise in design, implementation and maintenance of database management systems. On call and after hours support as required.
External ID
WXLLC-12375
Job Locations US-CA-San Diego
The Manager, Data Management is responsible for oversight of clinical data management functions on assigned projects and department line management.
External ID
WXPAC-1144
Job Locations US-NJ-Cranbury
WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life. Our New Jersey site specializes in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries.  We are seeking a DMPK Director within our DMPK Discorvery In Life Group located in Cranbury NJ. 
External ID
WXXBL-14721
Job Locations US-MN-St. Paul
The Quality Control (QC) Inspector examines incoming, in-process, and/or final product and subassemblies in our medical device contract manufacturing business. QC inspector may review, measure, visually inspect and release product.
External ID
WXINC-23423
Job Locations US-MN-St. Paul
Who we are: WuXi AppTec is a global leader in the pharmaceutical, biopharmaceutical, and medical device industries.  The Minnesota site in particular, is a rapidly growing global leader in the medical device testing industry, focusing on pre-clinical testing.  http://us.wuxiapptec.com/   The work we do and why we do it: Prior to medical devices (everything from bandages to advanced implantable devices such as a pacemaker) being used by patients and medical care practitioners, our clients must prove to regulatory agencies around the world, that their newly created medical devices have been demonstrated safe in our pre-clinical tests. Upon successful completion of pre-clinical testing, our clients work with regulatory agencies on moving to the next step in the process, human clinical trials.  Because of our unique business model in specialized pre-clinical testing, we are able to test medical devices during their R&D cycle, and often times see new medical devices years before they are visible and available to the public.   Department Description:   The Sample Receipt Coordinator within the Sample Receipt laboratory is critical to the overall success of the organization. The Sample Receipt laboratory receives the medical devices and associated test requests. They initiate the chain of custody for these materials. This chain of custody will allow for traceability of the medical devices throughout their entire testing lifespan. There are three main functions within the Sample Receipt lab:   Receipt of Test Articles (Medical Devices): Upon receipt of the medical devices (referred to as “test articles”), the Sample Receipt Coordinator will review the submission paperwork in tangent with the test articles themselves. An extremely high level of attention to detail is required to ensure that any discrepancies between the paperwork and the test articles are caught at this stage. Any discrepancies are later communicated to the client and clarified via email or conference call.   Login and Traceability of Testing Received: The Sample Receipt Coordinator will create a unique study number for each testing submission submitted by the client. This study number is created in an electronic chain of custody module. Within this study number, individual inventory will be created to represent each device submitted by the client. The device specific information will also be entered into this system. Labels can then be generated and are used to properly label and identify the material received.   Creation of Study Folders: Once the submission and applicable test articles have been logged into the chain of custody module, a separate study folder will be created for each test that is requested. This folder will contain the submission form submitted by the client, any additional instructions provided by the client, the protocol template (if applicable), and any relevant communication with the client. This folder will go to the study director for review and guide the lab technicians on how to prepare, extract, and test these devices during the testing life cycle.   Job Summary:  This position is responsible for logging in and maintaining traceability of all types of Test and Control/Comparison articles submitted on WuXi AppTec submission forms in compliance with GLP, GMP, and ISO standards. This position is also responsible for assembling physical study folders and communicating directly with clients about testing discrepancies. This position requires an understanding of Good Laboratory Practices and Good Manufacturing Practices (WuXi AppTec will provide training as needed). 
External ID
WXINC-23422

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