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Job Locations US-PA-Philadelphia
Responsible for supporting the development, implementation, and maintenance of the WuXi Biosafety Plan across all U.S. sites. The Corporate Biosafety Manager will be integral in the analysis and mitigation of all biological risks associated with facility activities.
Job Locations US-PA-Philadelphia
Responsible for providing construction, engineering oversight and maintenance services for a state-of-the-art, multi-product contract manufacturing and testing facility. General responsibilities include: developing operational requirements for equipment/systems, developing request for proposals (RFP’s) for Facilities’ projects and supervise overall corrective and preventative maintenance program for facility, equipment and systems to support operations. Specific responsibilities include: maintaining and operating mechanical and utility systems, troubleshooting equipment/processes, ensuring regulatory compliance, and supervising internal facilities technician staff, external contractors and writing reports.   Ensures staff members are appropriately trained to perform their assigned duties and are competent in Good Laboratory Practices and current Good Manufacturing Practices (cGMP). Interacts with Manufacturing, Testing, Materials Management, Maintenance, Quality Assurance, Quality Control and Process Development groups. As needed, interacts with internal/external subject matter experts (SME’s), material/equipment vendors and commercial partners.   Effectively supervises all facility maintenance operations to address compliance, customer, and business needs in a timely manner. Responsible for training, supervising and evaluating Maintenance staff. Also conducts employee performance appraisals in a timely and objective manner.   Remains current regarding technical systems maintenance requirements. Develops and/or modifies facilities/equipment/systems to be in a compliant state. Prepares Standard Operating Procedures (SOPs), Logbooks, material specifications and investigation reports. Ensures group compliance with appropriate regulatory and/or maintenance standards including but not limited to the Code of Federal Regulations (21CFR), Environmental Protection Agency (EPA), International Society of Pharmaceutical Engineers (ISPE), American Society of Mechanical Engineers (ASME), and/or Federal, State and Local EHS regulations and building codes.
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).
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.
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
Job Locations US-PA-Philadelphia
The Scientific Technical Writer is responsible for the preparation and implementation of documents, protocols, test methods, analytical transfer plans, risk assessments, reports, procedures, equipment change controls, training materials and other documents as required to support Laboratory Operations. The Technical writer must be able to organize, understand and present complex scientific and technical information at a level that is appropriate for people with technical and nontechnical backgrounds. The positon requires effective planning, scheduling, researching, and writing skills and is recognized as subject matter expert in a scientific discipline.
Job Locations US-PA-Philadelphia
Performs research & development activities and assay validations as required under supervision. Clearly documents all experiments according to SOPs and cGMP guidelines. Authors test methods and other technical documents, as needed. Performs laboratory maintenance duties. Works closely with Testing Operations during assay transfer and validation activities.
Job Locations US-PA-Philadelphia
Performs research & development activities and assay qualifications as required under supervision. Clearly documents all experiments according to SOPs and cGMP guidelines. Authors test methods and other technical documents, as needed. Performs laboratory maintenance duties. Works closely with Testing Operations during assay transfer and qualification activities.
Job Locations US-PA-Philadelphia
This position is required to work on shift and be on-site. The Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. High level job accountabilities included activities related to sterility assurance, manufacturing oversight, quality system and release of raw materials.   **PLEASE NOTE:  This is a 2nd shift position.
Job Locations US-PA-Philadelphia
Performs Cell Culture, qPCR 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. Sufficiently competent in science and may serve as a Qualified Trainer as needed. May have client-facing interaction. This position is Monday-Friday 1st shift.
Job Locations US-PA-Philadelphia
Independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the Viral Clearance lab for performance of biologic downstream purification process steps.  Manages resources that support Downstream Process Development Technology Transfer and performance of chromatography and filtration activities for Viral Clearance laboratory operations.  Strong understanding of cell culture processes.  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
Job Locations US-PA-Philadelphia
The Virus Production Supervisor provides on-the-floor leadership, schedule management, and timely document review to ensure seamless execution of processes per cGMPs. The primary objective of the Virus Production group is to maintain virus stock inventories. The process includes the culture of various cell lines, inoculation/infection with a target virus, harvest, purification, and testing for qualification of finished lots.
Job Locations US-PA-Philadelphia
Independent scientist who demonstrates technical knowledge and contributes to the overall operations of the Viral Clearance Department. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. 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.
Job Locations US-PA-Philadelphia
The Validation Specialist serves as the primary resource for development, execution, review, and approval of equipment qualification (including TCUs, laboratory equipment, computerized systems), change controls. This position will help monitor equipment/software processes for adherence to established procedures/regulatory compliance. Also provide assistance for equipment/software related issues and consults with Validation and Quality Assurance to resolve complex quality issues.
Job Locations US-PA-Philadelphia
Executes and delivers key strategic projects, which increase the capability and capacity of WuXi ATU located at Philadelphia Navy Yard. Applies engineering skills, and GMP knowledge in ATMP manufacturing and testing for project delivery from feasibility through commissioning/qualification and hand over to the end users. Coordinates with the requirements of other departments such as EHS, QA, Manufacturing, Testing Operations, and Facilities/Metrology for the overall project delivery. Directly responsible for technical coordination and tracking project targets and achievements.
Job Locations US-PA-Philadelphia
Responsible for supporting AD Operations team in contributing to the achievement of company and departmental goals and objectives. Supports material / reagent inventory management, equipment installation and maintenance, and monitoring of lab equipment and systems. Interacts with AD area SMEs to keep informed of laboratory activities and needs.
Job Locations US-PA-Philadelphia
Designs, plans, authors, executes, and leads internal research & development studies in the Analytical Development Analytical Technology team. This position specifically focuses on driving method efficiency in Analytical Technology. Candidate will also author and assist in the execution of assay qualifications under very limited supervision. Acts as a Technical Reviewer and assay trainer. Partners with Testing Operations during assay transfer and qualification activities.
Job Locations US-PA-Philadelphia
The AD Technical Writer is responsible for the preparation of protocols, test methods, analytical transfer plans, reports, procedures, and other documents as required to support AD operations. Must be able to organize, understand and present complex scientific and technical information according to WuXi SOPs and industry best practices.
Job Locations US-PA-Philadelphia
Performs validation, calibration, and qualification activities on instrumentation & equipment, and documents the results consistent with all applicable quality standards according to schedule. Perform preventative maintenance, troubleshooting, and repair on instrumentation and equipment when scheduled or required.
Job Locations US-PA-Philadelphia
Performs validation, calibration, and qualification activities on instrumentation & equipment, and documents the results consistent with all applicable quality standards according to schedule. Perform preventative maintenance, troubleshooting, and repair on instrumentation and equipment when scheduled or required.

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