WuXi AppTec

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Job Locations US-PA-Philadelphia
Founded in 2000, the WuXi AppTec Group is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 22,000 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 Group’s dream that “every drug can be made and every disease can be treated.”   The Sr. Director, HR Business Partner will provide a broad range of Human Resources expertise to support the achievement of business objectives of the WuXi AppTec. Acting as a partner to Senior Management, the incumbent will work closely with executives and other leaders to plan and execute strategic and tactical HR initiatives that are aligned with corporate and business unit goals. This position will report directly to the VP of Human Resources.
Job Locations US-PA-Philadelphia
: The external auditor’s function is to participate in all facets of audits and inspections – client, regulatory, internal, external, and vendor/supplier. This position participates in day-to-day supplier/vendor management/qualification program. The position also provides support for the PHL QA and corporate QA operations and management to implement regulatory strategies and ensure regulatory compliance.
External ID
WXATU-2337
Job Locations US-PA-Philadelphia
Independent scientist contributing to the development of early and late stage clinical manufacturing processes and commercial Cell Therapy manufacturing processes, with a focus on Cell and Gene Therapy programs and vector production. This position will work with a team of scientists and technical specialists responsible for process development, technology transfer and GMP manufacturing to ensure the application of well-designed unit operations for inclusion in routine manufacturing operations supplying clinical and commercial materials. Responsible for development, scale-up/out, and verification of clinical and commercial manufacturing processes. Contributes as to tech transfer and manufacturing activities as necessary
External ID
WXATU-2855
Job Locations US-PA-Philadelphia
Manages the staff and daily activities of warehousing and internal logistics for the Philadelphia campus. Manages domestic & international logistics (90% air) and compliance processes. Responsible for import/export permitting related to biological reagents/materials. Responsible for day-to-day activities to support regulatory compliance efforts of warehouse, import/export and internal logistics activities. Assists internal and external Supply Chains.
External ID
WXATU-1514
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-2832
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.
External ID
WXATU-2830
Job Locations US-PA-Philadelphia
Responsible for conducting experiments in order to support the development of upstream cell culture process platforms and client based processes with a focus on Cell and Gene therapy programs. The incumbent will actively participate in the execution of suspension and adherent cell culture experiments. This position will work with a team of scientists and technical specialists responsible for process development and technology transfer to ensure the application of well-designed unit operations for inclusion in routine manufacturing operations supplying clinical and commercial materials. Responsible for supporting development project leads in the development and scale-up of Cell and Gene therapy processes. Contributes to operations of development team, and may support tech transfer activities as necessary.
External ID
WXATU-2827
Job Locations US-PA-Philadelphia
Oversees the clinical Manufacturing group and is responsible for the operation of a state of the art Cell Banking and Advanced Therapy facilities. Works closely with support function leaders and Area Management to ensure day-to-day clinical MFG operations are performed within WuXi Quality standards. Maintains rigorous quality and HSE mindset and advocates strict adherence to compliance practices within the department and the facility. Working knowledge of clinical lifecycle from preclinical through late stage / early commercialization. Must have strong working knowledge of the technical and current Good Manufacturing Practice (cGMP) compliance requirements for manufacture of biologics.
External ID
WXATU-2823
Job Locations US-PA-Philadelphia
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 Analytical 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
External ID
WXATU-1837
Job Locations US-PA-Philadelphia
Oversees the key, core assay development groups within Analytical Development. Responsible for overseeing new method development, assay qualifications and validations, as well as internal and external assay transfers. Partners with Testing Operations management to transfer methods from Analytical Development to Testing Operations. Provides high-level technical support as needed. Manages assay functional leads and supervisors and is responsible for strategical planning, project timelines, appropriate resourcing, setting appropriate goals, and personnel development. Possesses rigorous scientific skills in biologics testing and a strong working knowledge of Good Manufacturing Practice (cGMP) compliance requirements for biologics testing. Remains current regarding regulatory testing requirements and develops / modifies assays in accordance. Remains current in the scientific areas of their respective functional areas and serves as a key subject matter expert to the organization. Engages clients and auditors regularly.
External ID
WXATU-1443
Job Locations US-PA-Philadelphia
Responsible for providing direct oversight and leadership in the 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).
External ID
WXATU-1238
Job Locations US-PA-Philadelphia
Designs and executes research & development studies, assay qualifications and test article validations under limited supervision. Drafts test methods and clearly documents all experiments according to SOPs and cGMP guidelines. 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 assistance by departmental senior staff.
External ID
WXATU-2809
Job Locations US-PA-Philadelphia
Designs and executes research & development studies, assay qualifications and test article validations under limited supervision. Drafts test methods and clearly documents all experiments according to SOPs and cGMP guidelines. 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 assistance by departmental senior staff.
External ID
WXATU-2808
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-2248
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-1148
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-2806
Job Locations US-PA-Philadelphia
Maintains current knowledge of compliance guidelines and requirements related to advanced therapy manufacturing and testing. Designs, plans, authors, and executes research & development studies, assay qualifications and test article validations. Leads method development projects. Acts as a Technical Reviewer and assay trainer. Partners with Testing Operations during assay transfer and qualification activities.
External ID
WXATU-2805
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-2804
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-2802
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-2801

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