WuXi AppTec

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Search Results Page 5 of 13

Job Locations US-PA-Philadelphia
Performs daily, weekly, and monthly analysis of the Environmental Monitoring System (EMS). Perform statistical evaluation of data from the EMS to evaluate equipment reliability, suitability, and proper response to out of specification conditions by end users. Report finding and document the results consistent with all applicable quality standards according to schedule. Ensure preventative maintenance, troubleshooting, proper operation and repair on equipment has a positive impact on equipment reliability.
External ID
WXATU-3032
Job Locations US-PA-Philadelphia
Responsible for supervising Quality Control activities within the production facility. Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives. Has a strong working knowledge of the regulatory compliance requirements for the production of biologics used in clinical studies. Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to fully address compliance issues. Demonstrates innovative technical knowledge and significantly contributes to the overall operations of the lab. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. Participates in manufacturing operations in assigned area per cGMPs. Analyzes scientific data with accuracy and precision, critical at time of processing.
External ID
WXATU-3031
Job Locations US-PA-Philadelphia
Performs and directs assays 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). 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. Schedules and directs assays. Assists with training junior staff members. Performs Research & Development activities. Acts as Study Director as required. Assists supervisor with day-to-day lab management duties. Correctly analyzes scientific data with accuracy and precision.
External ID
WXATU-3028
Job Locations US-PA-Philadelphia
Performs and directs assays 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). 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. Schedules and directs assays. Assists with training junior staff members. Performs Research & Development activities. Acts as Study Director as required. Assists supervisor with day-to-day lab management duties. Correctly analyzes scientific data with accuracy and precision.
External ID
WXATU-3027
Job Locations US-PA-Philadelphia
Responsible for providing support in performance of activities within production facilities to support the manufacture of Master and Working Cell Banks Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).
External ID
WXATU-3015
Job Locations US-PA-Philadelphia
Responsible for the daily operations of the Analytical Development Laboratories. Oversees equipment and materials in both areas to ensure the technical teams are always operational and setup to deliver new programs on time. Maintains the compliance and safety of the laboratories.
External ID
WXATU-1384
Job Locations US-PA-Philadelphia
Performs research & development activities and assay validations as required under direct supervision. Drafts test methods and clearly documents all experiments according to SOPs and cGMP guidelines. Performs laboratory maintenance duties. Works closely with Testing Operations during assay transfer and validation activities.
External ID
WXATU-1854
Job Locations US-PA-Philadelphia
Maintains current knowledge of regulatory guidelines and requirements related to control and testing of raw materials for advanced therapy manufacturing. Authors and revises controlled documents to support material onboarding and risk management. Performs verification of Material Item Masters and works cross-functionally with Supply Chain and Quality Assurance. Creates and maintains end-user resources and tools. Supports delivery of client-specific material risk control and assessment documents as needed.
External ID
WXATU-2104
Job Locations US-PA-Philadelphia
Designs, plans, authors, and executes research & development studies, assay qualifications and test article validations under very limited supervision. Leads method development projects. Acts as a Technical Reviewer and assay trainer. Partners with Testing Operations during assay transfer and validation activities. Participates in client calls and face to face meetings with limited assistance by departmental senior staff.
External ID
WXATU-1356
Job Locations US-MN-St. Paul
The Study Specialist is responsible for assisting study directors in the management, scheduling, and investigations associated with nonclinical studies contracted to WuXi AppTec by its Clients/Sponsors. This position requires an ability to work across internal working groups to assist in the planning, execution, and completion of nonclinical studies that meet Sponsor and regulatory requirements.
External ID
WXINC-23386
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 serves as the interface between the St. Paul facility, Subcontract Laboratories and the Sponsor in terms of study planning, organization, execution, data analysis and final report construction. Tasks executed within the department can be placed into the following three categories in most cases. - Pre-study phase that include but is not limited to study protocol and worksheets development, IACUC protocol development, client communication, scheduling the study. - In-Life phase involving providing 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. - Reporting phase involving study data review, recognizing and initiating any deviations from the protocol and Standard Operating Procedures, drafting and finalization final report, and engaging with Quality Assurance during report review process as required.   Job Summary:  Responsible for all aspects of custom studies performed within In-Life Services (ILS) at WuXi AppTec. The Study Director – Customs interfaces between the St. Paul facility, Subcontract Laboratories and the Sponsor in terms of study planning, organization, execution, data analysis and final report construction. They will handle all resource planning and sponsor communication to complete the assigned studies on time.
External ID
WXINC-23412
Job Locations US-PA-Philadelphia
Manages the Molecular Biology operations and staff to ensure day-today testing operations are performed. Demonstrates leadership in a fast-paced setting and operates with minimal oversight and a clear understanding of business and regulatory demands. Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of Molecular Biology, and excellent understanding of current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) compliance requirements. Efficiently manages staff and other resources to address scientific, business and regulatory needs in an effective and timely manner. Interacts with internal and external customers and auditors as needed to provide support and address any comments/issues. Leads process improvements and performance metrics for the Molecular Biology operations team. Remains current regarding best practices and develops or modifies procedures to stay fully compliant with the evolving expectation of all clients. Prepares protocols and standard operating procedures (SOPs), and reviews and approves work of team members. Schedules, manages, and conducts testing activities, keeping appropriate records consistent with regulatory guidance, business needs and client expectations. Gather and collate results, identifies trends, interprets implications, and recommends procedural changes to drive improvement. Communicates with Management, Quality Assurance and other as appropriate. Participates in development and implementation of validation plans and protocols. Effectively assists with client and regulatory interactions as appropriate.
External ID
WXATU-2785
Job Locations US-PA-Philadelphia
Associate Scientist in Molecular Biology acts as Independent Technical Reviewer and has ability to operate in a fast paced, rigorous cGMP testing environment. Responsible for technical review of GMP documents to ensure correct interpretation, analysis, documentation, and reporting of results. Generates R&D and validation reports, GMP documents and GMP Test Methods. Oversees assays and investigations according to and in compliance with current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and Standard Operating Procedures (SOPs).
External ID
WXATU-3009
Job Locations US-PA-Philadelphia
Laboratory Technician III in Molecular Biology will be responsible for performing nucleic acid based assays where proficiency in nucleic acid extraction methods and qPCR is required. Independent data analysis experience required. Preferred experience in a GMP and/or high throughput lab where day to day activities are heavily driven by meeting deadlines. Experience with automation and LIMS systems a plus.
External ID
WXATU-1919
Job Locations US
WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.   Founded in 2000, the WuXi AppTec is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 25,000 employees across 25 locations globally. The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec’s dream that “every drug can be made and every disease can be treated.”
External ID
WXRPG-2328
Job Locations US
WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.   Founded in 2000, the WuXi AppTec is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 25,000 employees across 25 locations globally. The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec’s dream that “every drug can be made and every disease can be treated.”
External ID
WXRPG-2327
Job Locations US-PA-Philadelphia
Independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the lab. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives. Performs and directs assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Acts as Study Director as required.
External ID
WXATU-3003
Job Locations US-PA-Philadelphia
Independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the lab. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives. Performs and directs assays according to and in compliance with current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs).
External ID
WXATU-2996
Job Locations US-CA-San Diego
WuXi HDB San Diego is looking for a Clinical Laboratory Scientist to join our team!   The candidate must be detailed-oriented, and is qualified and able to work productively in a high-complexity CLIA laboratory in the State of California. The candidate will be responsible to laboratory leadership for ensuring his/her area of responsibility meets licensure/inspection requirements at all times, that all quality control is performed and documented according to company’s policies/procedures, and State and Federal regulations. Duties will include specimen receiving, logging, processing, testing, test result analysis, data uploading in LIMS, and reporting to Director, clients, and regulatory agencies. S/He will also be responsible for routine maintenance of laboratory, reagent inventory, equipment, records etc., as well as training and supervision of non-licensed laboratory personnel. The candidate will also be involved in new assay development and qualification, communication with accreditation agency and California Department of Public Health as needed.
External ID
WXHDB-1487
Job Locations US-CA-San Diego
WuXi HDB is looking for a Sr Scientist in San Diego.   The candidate for this position will be responsible for performance of experiments to support in vitro screening and/or evaluation of small molecule and biologics drug candidates. The position requires experience and exceptional skills in Molecular biology, Cell Biology, and Biochemistry techniques. Prior experience with medium- to high-throughput screening, high-content imaging, liquid handlers, fluorescence and luminescence-based assay platforms is highly desirable. Candidates with virology research experience will be given preference.
External ID
WXHDB-1404

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