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Performs research & development activities for Next Generation Sequencing studies 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.
Leads the orderly progression of internal projects from Project Kick Off through Project Completion. The projects managed will primarily be in support of the Testing Operations business. Projects will be focused on internal testing operations with a mix in the scale of projects being simple to complex.
Maintains current knowledge of regulatory guidelines and requirements related to control and testing of raw materials for advanced therapy manufacturing and provides guidance to Manufacturing and Process Development Departments and core teams. Performs material verification and suitability review to support creation of program-specific control strategies. Participates in client calls and face-to-face meetings with limited assistance by departmental senior staff. Supports material-related investigations and assessments.
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.
Designs, plans, leads, authors, executes, and interprets research & development studies, assay qualifications and test article validations. 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. Leads and drives technical discussions both internally and externally. Interfaces with Sales team regularly and authors custom quotes as needed.
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.
The Automation Specialist will champion the transition of manual assays to automated platforms (such as Tecan Liquid Handling instruments) and associated activities. This position will be primarily responsible for leading the translation of Molecular Biology methods into automated workflow for nucleic acid extraction, PCR setup, etc. The Specialist is also responsible for troubleshooting scripts/ as well as instrument operations. Responsibilities will extend to other existing automated instruments and include onboarding new equipment to meet evolving operational needs. The incumbent must be able to recognize and solve instrument problems to minimize outages. This position will oversee equipment maintenance and associated accessories and proactively manage the stock of parts and consumables. Must be motivated and be able to work independently to meet project goals.
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.
The Senior Sample Coordinator coordinates the day to day operations of the Sample Transfer team. This team is responsible for the processes involving manufactured sample receipt, sample tracking, sample inventory, sample disposal and sample logistics. This includes communicating with multiple departments and sites within Wuxi.
Executes and delivers key strategic projects with minimum supervision, to increase the capability and capacity of WuXi AppTec Manufacturing and Testing Operations in cell and gene therapies. Applies engineering skills and GMP knowledge for sterile drug manufacturing for all aspects of project delivery from feasibility through start up and hand over to the end users. Aligns the requirements of other functional groups such as EHS, QA, Manufacturing, Testing, and Facilities/Metrology for overall project delivery. Directly responsible for tracking project cost, schedule, targets and achievements.
Support process equipment introduction and process improvements to increase the capability and capacity of WuXi ATU in cell and gene therapies. Apply process engineering principles and GMP knowledge in manufacturing of Advanced Therapy Medicinal Products (ATMPs) to improve and troubleshoot current processes. Directly responsible for meeting user requirements and project schedule for project delivery from feasibility through commissioning/qualification, and hand over to the end users. Coordinate with other functional groups such as EHS, QA, Manufacturing, Testing Operations, Process Development, Facilities, Metrology, Validation, and IT for project delivery.
Responsible for the daily operations in the manufacture of the following: Cell Banks, Viral Vectors, Cell Therapy, and Gene Therapy products following Current Good Manufacturing Practices. Knowledge of cell culture operations and support systems is essential. Demonstrates managerial skills and a strong working knowledge of the regulatory compliance requirements for the production of biologicals used in clinical studies are essential. Demonstrates a clear understanding of the contract manufacturing business and effectively manages all Cell Banking operations to address compliance, customer and business needs in a timely manner. Responsible for hiring, training, supervising and evaluating staff. Remains current regarding technical manufacturing requirements and develops / modifies production methods to fully address such issues. Reviews and approves, SOPs, and new client master batch records. Manages operations assuring customer satisfaction and compliance with appropriate regulatory standards including but not limited to the Code of Federal Regulations (CFR), United States Pharmacopia (USP), and/or Points to Consider (PTC).
The EHS Field Coordinator will be responsible for supporting EHS compliance and risk management within the PHL Campus. The EHS specialist will monitor and improve processes to prevent and eliminate injury and illness to employees and assist the company to comply with safety laws.
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.
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. Demonstrates strong oral and written communication skills, and supports client-facing activities for the Cell Therapy Process Development team.
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.
Performs cell culture and cell-biology based 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).
Responsible for providing technical writing support to Sterility Assurance
for excursions within a manufacturing GMP facility. Perform root cause analysis to
discover the main issue and how it can be resolved..
Performs facilities duties according to Standard Operating Procedures (SOPs) and Industry Standards
Main function is release of raw materials intended for Manufacturing. Assists in the preparation of Standard Operating Procedures (SOPs). Assists in the documentation of Non-conforming events (NCEs).
Reviews laboratory test data and performs inspections in accordance with current Good Manufacturing Practices (GMPs), Evaluates systems and procedures as assigned in consultation with Supervisor.