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Responsible for partnering with the Business Unit CEO and the Sr. Leadership Team, the VP US HR, and the site HR team to provide strategic & tactical support in multiple HR functions with a focus on shared services, employee relations & performance mgmt.Serve as a member of the Sr. Leadership Team to drive US & ATU HR objectives and to provide advice and counsel to focus on creating innovative HR solutions that support the business strategy
WuXi is looking for a leader with the breadth of professional experience, passion, drive and excellent collaboration and customer focus to define and implement his/her vision for this business critical function. The Product Director will be responsible for the delivery of WuXi’s Cell Therapy portfolio. The Product Director is responsible for end to end product leadership including product strategy, development, supply and life cycle management planning for both commercial and pipeline products. This is a leadership role that requires working in a matrix organization with Product and Analytical Development, Operations, Supply Chain, Quality and Regulatory teams as well as Sales.
Independent scientist contributing to the development of early and late-stage clinical manufacturing processes and commercial Advanced Therapy manufacturing processes, with a focus on 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 Process Development team.
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). Serve as the departmental trainer, as needed.
Sufficient scientific training and competence to perform basic complexity Flow Cytometry and/or Cell Based Assays according to, and in compliance with, current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). As part of standard work, completes assigned Test Methods and 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.
The ideal candidate will have basic flow cytometry theory and/or instrumentation and complete site training in flow cytometry assays using 1-4 colors. Experience in mammalian cell culture is desirable but not a requirement.
Flow Cytometry Specialist is required to perform sufficient scientific training and competence for basic and moderate complexity Flow Cytometry and/or Cell Based Assay according to, and in compliance with, current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). As part of standard work, completes assigned Test Methods, assay development, other required documentation and general laboratory duties. Candidate will have basic or working knowledge of flow cytometry theory and/or instrumentation and experience in flow cytometry assays using 1-4 colors. Also will also have experience in mammalian cell culture and/or ELISA based assays. Experience in cell based potency assays (i.e. cell proliferation, cell killing, etc.) is desirable but not a requirement
The Senior Commercial Service Manager oversees the delivery of products to clients and is the primary contact for clients. The Senior Commercial Service Manager will manage on-time delivery, drive standard actions and deliverables, as well as, lead the team in solving technical challenges that could impact the ultimate delivery of the product to the Patient. Communicates and coordinates with the client and internal stakeholders. The Commercial Services Manager has an in depth understanding of the processes and systems associated with managing client activities, with a solid understanding of the technical aspects of a project.
The Manager coordinates and oversees the day-to-day aspects of the QA staff, including training and development of QA staff. Monitor and maintain compliance with current regulatory requirements (cGMP, GLP, GTP, CFR, PTC and ICH) and internal SOPs. Drive continuous quality improvement through communication/training, waste reduction, and mistake-proofing.
The Sr. Scientist will be responsible for supporting upstream cell culture process platforms as well as developing and assisting client based processes with a focus on Cell and Gene therapy programs. The incumbent will actively participate in the development of suspension and adherent cell culture processes as well as vector production and transduction methods. In addition, the candidate will contribute in the continuous improvement of WuXi Advance Therapies Unit infrastructure and capabilities for upstream process by implementing new technologies. The candidate will work with his immediate supervisor to establish and execute work plans associated with client base projects and development of new platforms for Cell and Gene therapy.
Scientist responsible for conducting experiments independently 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 planning and execution of suspension and/or adherent cell culture experiments. This position will work with a team of technical specialists, scientists and subject matter experts to ensure the development of robust processes and application of well-designed unit operations for inclusion in routine manufacturing operations supplying clinical and commercial materials. Responsible for leading and supporting WuXi internal platform as well as client based projects. Contributes to operations of development team, and support tech transfer activities as necessary.
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).
Works closely with Director of Manufacturing, Manufacturing Managers and support functions to manufacturing in 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).
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.
Provide technical writing for the Advanced Therapy business unit to prepare detailed proposals, SOPs, and other technical documents for cell and gene therapy development programs. Collaborate with manager and Process Development and Analytical Development team members to prepare high quality client proposals and other documents detailing the service offerings of WuXi AppTec. This responsibility consists of translating process development and tech transfer information from customers, and the process and analytical development teams for cellular therapeutics or gene therapy vector production. Understanding of client information on different technologies, unique cell processes, upstream / growth as well as downstream / purification for viral vectors, as well as autologous and allogenic therapies would be important.
Provide software application support and business analysis to deliver high quality, value-add systems to the WuXi Advanced Therapies business unit (ATU). This role will primarily focus on the implementation of new LIMS software (LabVantage
LV Pharma LIMS) to support the ATU Testing business. Additionally, the role may provide support and analysis for other third party applications, such as STARLIMS, SAP Business One, Microsoft Dynamics GP and CRM, and Microsoft SQL Reporting Services, or for WuXi custom applications.
***This is a permanent full time opportunity including benefits, 401k and PTO.
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).
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). Under direct supervision, completes test methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs.
Independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations at WuXi Advanced Therapies. This person will advise organizational leadership on products and processes that are technical in nature and interact with external agencies. Act as a Subject Matter Expert and perform the following kinds of functions: Initiate, supervise, and/or develop requirements from a project’s inception to conclusion for complex to extremely complex programs. Provide strategic advice, technical guidance and expertise to program and project staff. Provide detailed analysis, evaluation and recommendations for improvements, optimization development, and/or maintenance efforts for client-specific or mission critical challenges/issues. 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).
Drives the automation of various biological and biochemical assays by evaluating new automation technology and recommending appropriate platforms to Management. Onboards and programs new instrumentation to deliver equivalent or improved methods as compared to original manual method. Serves as Subject Matter Expert and Primary Trainer for automated equipment. Partners with Testing Operations during assay transfer and validation activities.
The Technical Specialist will be responsible for providing expertise, consultation and technical guidance for Philadelphia Biological testing services. The Technical specialist will work closely with Clients, Sales, Project Management and Operations to provide guidance with respect to testing programs based on the Product Type, Phase in clinical development and regulatory requirements. They will recommend appropriate assays and sample requirements per WuXi AppTec’s Testing Platforms, assist with development of testing quotes, and field technical questions from external and internal clients.