WuXi AppTec

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Job Locations US-PA-Philadelphia
Responsible for providing technical support to the Metrology department, in aspects of the equipment life cycle (calibration, and qualification activities on instrumentation & equipment) and takes point on Metrology related Quality events and investigations.
External ID
WXATU-1615
Job Locations US-PA-Philadelphia
The Quality Systems Specialist is responsible for administering Quality Systems processes, including: issuance, tracking, implementation, and obsoletion,of all controlled document types, while ensuring accordance with current Good Manufacturing Practices (cGMP) for Manufacturing and Laboratory studies. Supports the day to day administration of the QMS, MasterControl system.
External ID
WXATU-1097
Job Locations US-PA-Philadelphia
This is a CMC Lead position within the Process and Technical Development Department that has responsibility to lead early and late stage gene and cell therapy programs. This position will work with a team of scientists and technical specialists responsible for process development, program management and GMP manufacturing to ensure the technology transfer of a well-designed unit operations for inclusion in routine manufacturing operations supplying clinical and commercial materials. Demonstrates strong oral and written communication, interpersonal and collaborative skills. Supports client-facing activities for the project team, including weekly meeting, program update, issue resolution, documentation and regulatory filings. Contributes to the achievement of company and departmental goals and objectives.
External ID
WXATU-2234
Job Locations US-PA-Philadelphia
The Vice President of Quality Assurance and Regulatory Affairs (VP QA/RA) is responsible for the management, development, implementation and coordination of the regulatory affairs and quality assurance functions with a focus on understanding, implementing and ensuring compliance with global quality/regulatory requirements for the site. The VP QA/RA will establish quality system, plans and policies and report to senior management on a regular basis on compliance activities and findings. He/she will design, implement and maintain QA and compliance programs and infrastructure including an SOP system, training program, sterility assurance program, perform internal and external audits, and create and maintain regulatory documents (license, DMFs, etc.). The VP QA/RA will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. The VP QA/RA will serve as an in-house subject matter expert on GxP compliance and regulatory affairs. He/she will also serve as key customer-facing senior quality and regulatory leader to ensure the full alignment between customers and ATU on all quality, compliance and regulatory topics. The VP of QA/RA will lead and drive the regulatory submissions and inspections to enable successful commercial licensing.
External ID
WXATU-1393
Job Locations US-PA-Philadelphia
The Sr. Project Manager is the lead on client projects of varying size, complexity and of strategic importance to the business. The Sr. Project Manager will perform timeline management, drive project actions and deliverables, and lead the team to solve challenges that affect the project scope, timeline and / or budget while meeting the overall project or business goal(s). Communicates and coordinates with the Client and internal stakeholders.   ***PHARMACEUTICAL OR BIOTECH EXPERIENCE IS MANDATORY FOR THIS POSITION.
External ID
WXATU-2226
Job Locations US-PA-Philadelphia
Provide supply chain leadership for the overall platform business including but not limited to planning and materials management.
External ID
WXATU-2217
Job Locations US-PA-Philadelphia
Responsible for developing in process and release testing strategies that meet federal agency requirements for various internal and external manufacturing programs for cell and gene therapy products. Lead development and transfer of assays that are needed to characterize and release cell and gene therapy products. This position requires continual interaction and collaboration with Clients as well as WuXi AppTec internal departments such as Client Delivery, Testing Operations, Quality Assurance, Process Development, Technology Development, and Manufacturing, in addition to working with colleagues in Analytical Development.
External ID
WXATU-1389
Job Locations US-PA-Philadelphia
Independent Sequencing Scientist who demonstrates advanced technical sequencing expertise, particularly Next Generation Sequencing (NGS), and significantly contributes significantly to sequencing operations in the Molecular Biology Testing lab. Demonstrates strong oral and written communication skills and actively contributes to staff training. Generates GMP, R&D and validation reports, GMP documents and GMP Batch Records in role as Sequencing Study Director/ Technical Reviewer. 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-2201
Job Locations US-PA-Philadelphia
Acts as the Primary Quality Assurance Representative for designated clients. Review and approval of GMP Certificates of Analysis (CoA’s), deviations, and CAPAs. Reviews, as necessary manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP)
External ID
WXATU-1196
Job Locations US-PA-Philadelphia
Develops Policy, strategy, and operations for all business unit procurement; including sourcing, negotiating long-term strategic contracts, leading business review meetings and steering teams with senior executives, establishing and controlling performance metrics for strategic accounts, and directing efforts for improvement activities across the strategic suppliers.
External ID
WXATU-2163
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-2148
Job Locations US-PA-Philadelphia
Independent Scientist with extensive theoretical and practical expertise in qPCR able to significantly contribute to Residual DNA testing within the Molecular Biology Department. Demonstrates strong oral and written communication skills in the capacity of a Technical Reviewer to review and generate GMP documentation including Certificates of Testing/Analysis, R&D and validation reports, Test Methods and Standard Operating Procedures (SOPs). Able to interface and collaborate with multiple stakeholders including clients, external vendors, Quality Assurance, Client Delivery, Management and laboratory staff. Demonstrates strong leadership skills to drive 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 SOPs.
External ID
WXATU-2147
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-2085
Job Locations US-PA-Philadelphia
Support assigned departments by promoting, communicating and implementing human resources strategies and initiatives. Build and maintain influential relationships by being a strategic partner with management. Provide legal advice, coordinate performance management, and resolve employee relations issues. Act as experts on human resources policies and procedures such as Benefits, compensation, and employee development
External ID
WXATU-2045
Job Locations US-PA-Philadelphia
Senior Laboratory Technician in Molecular Biology will be responsible for performing nucleic acid based assays where high level of proficiency in nucleic acid extraction methods and qPCR is required. High proficiency with independent data analysis 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-1892
Job Locations US-PA-Philadelphia
Performs assays according to testing records 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. Serve as departmental trainer, as needed.
External ID
WXATU-1811
Job Locations US-PA-Philadelphia
Responsible for 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).
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-1989
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-2005

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