WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Media Prep department for an Associate Sterilization Technician.  This position will work to prepare various media in compliance with GLP, GMP and ISO standards.

HD Biosciences, a WuXi AppTec company is searching for a Senior Research Associate to join our growing Immuno Oncology and In Vivo Pharmacology team.

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.

HD Biosciences Inc., a WuXi AppTec company, located in San Diego, is looking for a highly motivated biology intern to join our assay development team to support cell based assay and biochemical assay projects.

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.

  WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life. Our New Jersey site specializes in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries.  We are seeking a Scientist I within our Large Molecule Group located in Plainsboro, NJ. 

WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Technical Development Department for a Laboratory Coordinator.  The Laboratory Coordinator adheres to client study timelines, coordinating with laboratory schedules so study results are generated on time and prepares the final client study report. May interact with: clients to ensure samples and materials are received, account managers to ensure accuracy of quotes, laboratory personnel to review study protocols and testing design, WuXi AppTec subcontractors, and Technical Services team members as appropriate.

WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Technical Development Department for a Laboratory Coordinator.  The Laboratory Coordinator adheres to client study timelines, coordinating with laboratory schedules so study results are generated on time and prepares the final client study report. May interact with: clients to ensure samples and materials are received, account managers to ensure accuracy of quotes, laboratory personnel to review study protocols and testing design, WuXi AppTec subcontractors, and Technical Services team members as appropriate.

WuXi AppTec Laboratory Testing Division’s International Marketing Team is looking for a Downstream Sr. Product Manager to join our team. We are leaders in providing services to global Pharmaceutical and Medical Device manufacturers that support the product life cycle from new drug discovery to regulatory submissions for new products and life-cycle management for existing product lines. However, we need to increase our team when it comes to developing strategic downstream marketing plans for the services driving our business. The Product manager will be responsible for developing, initiating, creating and executing an annual downstream marketing strategy that supports our current strategic business initiatives and supports meeting revenue targets. We are looking for someone with proven abilities in B2B marketing who has experience in developing and executing integrated marketing programs with proves success. Our Product managers work closely with our finance, technical, operations, sales team, customers, industry experts and regulatory agencies to do their job; so demonstrated ability to lead in a matrixed organization (cross-functional) team is necessary.