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Job Locations US-PA-Philadelphia
Provides leadership for the Viral Clearance testing group and works closely with the groups’ managers and supervisors to ensure day-to-day testing operations are performed. Maintains rigorous quality mindset and advocates strict adherence to compliance practices within the department. Possesses rigorous scientific skills in the specific science area and a strong working knowledge of the technical and Good Laboratory Practice (GLP) / current Good Manufacturing Practice (cGMP) compliance requirements for biosafety testing. Provides a strategic direction for the development of the Viral Clearance operations business. Remains current regarding biosafety testing requirements and develops / modifies assays to fully address such issues. Remains current in the scientific areas of Viral Clearance, Virology and Cell Biology. Prepares study protocols and Standard Operating Procedures (SOPs), assists in preparing new client protocols and revises documents as needed. Works with Sales and Marketing teams to develop the Viral Clearance business including customer site visits, strategic planning and budget development.
External ID
WXATU-1544
Job Locations US-PA-Philadelphia
Performs any basic to complex 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 projects. Performs and thoroughly documents Research & Development activities as required.
External ID
WXATU-2632
Job Locations US-PA-Philadelphia
Performs basic and next-level Analytical 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). Completes Test Methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs and thoroughly documents Research & Development activities as required. Performs daily work activities with minimal supervision.
External ID
WXATU-2631
Job Locations US-PA-Philadelphia
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 for selected assays
External ID
WXATU-2629
Job Locations US-PA-Philadelphia
Associate responsible for performing activities within the process development area to develop early and late-stage clinical as well as commercial Cell and Gene Therapy manufacturing processes. Contributes to the overall operations of the process development team, with a focus on technical execution in the development laboratories as well as maintenance of the laboratories and laboratory quality systems. Contributes to the achievement of company and departmental goals and objectives.
External ID
WXATU-2622
Job Locations US-PA-Philadelphia
Performs virology, safety, and advanced therapy assays according to testing records and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
External ID
WXATU-2616
Job Locations US-PA-Philadelphia
Performs virology, safety, and advanced therapy assays according to testing records and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
External ID
WXATU-2615
Job Locations US-PA-Philadelphia
Performs virology, safety, and advanced therapy assays according to testing records and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
External ID
WXATU-2614
Job Locations US-PA-Philadelphia
Performs virology, safety, and advanced therapy assays according to testing records and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
External ID
WXATU-2613
Job Locations US-PA-Philadelphia
Independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the Virology Department. 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. Manages resources that support client facing Virology laboratory operations. Supports management of laboratory schedule with operations team. 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. The schedule is Monday-Friday 1st shift. During covid, employee will work from home 3 days per week. 
External ID
WXATU-1007
Job Locations US-PA-Philadelphia
Assist the Vice President of Quality and Regulatory to strategize, organize and implement the Global Quality and Compliance Operations at WuXi Advanced Therapies. The candidate is expected to work closely with the Quality and Compliance Management team at all WuXi Advanced Therapies locations to first understand the individual site quality and compliance operating model, then create a proposal for roles, functions, processes and systems that should be globalized, harmonized, standardized, or remained as location specific. Thereafter, the candidate will lead a team of quality professionals to implement the proposal to build the Global Quality and Compliance organization for WuXi Advanced Therapies. The scope of work includes developing global policies and procedures to govern all operational aspect of quality oversight and leadership in support of the manufacture of master and working cell banks, cell & gene therapy products, final products fill and finish, and the external testing operations according to current Good Manufacturing Practices. The success measures include leading the effort to achieve standard interpretation of major health authorities’ regulations, guidance, and best practices for phase appropriate quality system; direct department employees, resources and programs to ensure compliance with all regulatory requirements that are of interest to the clients globally, specifically with current Good Manufacturing Practice (cGMP), US Code of Federal Regulations (CFR), EU Guide to Good Manufacturing Practices, China GMP 2010 and Annexes, International Conference on Harmonization (ICH), Good Tissue Practices (GTP) and relevant foreign regulatory guidelines for biopharmaceuticals. The individual is also accountable to ensure compliance of critical functions for the sites; monitor, trend and report on all aspects of the quality and compliance performance by working with the local Quality departments and with other departments to meet goals and objectives.
External ID
WXATU-2611
Job Locations US-PA-Philadelphia
Responsible for managing day-to-day compliance for Cell and Gene Therapy Manufacturing operations to ensure processes are capable, compliant, in control, and continuously improved, in accordance with current Good Manufacturing Practices (cGMPs) and HSE. Works closely with Manufacturing Managers and various support functions to provide direct oversight of the following: o Facilitation, Execution, and Response of audits and inspections, and prospective client tours. o Corrective/preventive actions (CAPAs) and associated Standard Operating Procedures (SOPs), action plans, and training plans. o Compliance metrics maintenance o Technical documentation authoring, review and approval.
External ID
WXATU-2609
Job Locations US-PA-Philadelphia
The Lead Flow Cytometry Specialist completes assigned Test Methods, assay development, other required documentation and general laboratory duties according to relevant cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision with a heavy emphasis on training other technicians.
External ID
WXATU-1420
Job Locations US-PA-Philadelphia
Plan and manage the flow of raw materials throughout the entire supply chain. 
External ID
WXATU-2194
Job Locations US-PA-Philadelphia
The Demand Planning Manager is responsible for analyzing forecasts, demand variability, and working directly with Supply Chain Production Planners and the PD, Sales & Testing Ops, & Marketing Forecast Analyst to review monthly demand forecasts for short and long term planning. The Demand Manager is also responsible for leading the monthly S&OP meetings and conducting monthly internal Demand Meetings. Site scheduling for manufacturing production.
External ID
WXATU-2595
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. This is a Monday-Friday 2nd shift role (2:00pm-10:30pm) 
External ID
WXATU-1750
Job Locations US-PA-Philadelphia
Maintains current knowledge of regulatory guidelines and requirements related to advanced therapy manufacturing and testing. Supports tracking and dissemination of new and revised regulatory requirements and guidance; supports execution of required actions as needed. Review controlled documents for implementation of new and / or changed requirements. Coordinates with Technical Compliance Review Board Chairperson and relevant functional Subject Matter Experts to manage documentation and reporting in support of action closure / approval. Participates in on-site and / or virtual audits of external suppliers and business partners as needed.
External ID
WXATU-2591
Job Locations US-PA-Philadelphia
Reviews, coordinates, and assists to ensure non-conformances are adequately investigated for determination of root cause and product impact per FDA regulations. Using Root Cause analysis training, manage and coordinate laboratory investigations (out-of-specification, out-of-trend, non-conformance, and deviation). Ensures corrective and preventive actions (CAPA) are identified and implemented to prevent/reduce reoccurrence. Authors and leads change controls associated with laboratory equipment. Provides support for drafting/revision of existing documentation (SOPs, Test Methods, etc.).
External ID
WXATU-1710
Job Locations US-PA-Philadelphia
Performs Cell Culture and Cell-Based assays (BSL2 and BSL2+) 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 batch records 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. This position is Tuesday-Saturday 1st Shift. 
External ID
WXATU-1388
Job Locations US-PA-Philadelphia
Independent Scientist with in-depth knowledge of Next Generation (NGS) and Sanger Sequencing technologies to direct GMP testing as well as research and development as needed. Functions as a technical reviewer and subject matter expert under limited supervision. Demonstrates solid proficiency in scientific theory and rigorous practical application in the completion of lab procedures. Drafts test methods and clearly documents all experiments according to SOPs and cGMP guidelines. Demonstrates strong oral and written communication skills and actively contributes to staff training. Designs and participates in the execution of assay qualifications and test article validations. Participates in client calls and face to face meetings with assistance by senior staff. Maintains testing schedule and acts as a liaison with Client Delivery to meet timelines. Partners with Analytical Development during assay transfer and validation activities. This is a Monday-Friday 1st Shift role.
External ID
WXATU-2589

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