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 a Sterilization Technician.

Contributes to the team’s shared responsibility of supporting existing research projects, building new technologies into drug discovery platforms, and developing new algorithms for cheminformatics and deep learning.

CMC Project Management for Pharmaceutical Development Services (PDS) at STA Pharmaceutical Co Ltd., A WuXi AppTec Company

The Supervisor is responsible for organizing, planning and managing the personnel, systems and resources necessary to support chromatography. The individual will perform a variety of analytical tests based on Sr. Scientist level responsibilities.

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 an Associate Quality Assurance Specialist within our Quality Assurance Group located in Plainsboro, NJ. 

Perform payroll, accounting and administrative duties to support the Payroll Department including processing payroll, auditing, reporting, system maintenance, taxes, customer service and resolving payroll issues.

HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its in vivo Pharmacology Division. We’re seeking highly skilled and motivated Scientist to join the team.

This is a full time position, reporting to the Manager, Warehouse Operations.  The Warehouse Operations Lead will be a key member of the Manufacturing Support Operations team and will work independently and in a team to manage the inventory of raw materials, consumables, cell banks, drug substance, etc. in cGMP compliant warehouses.

Provides leadership for the Viral Clearance testing group and works closely with the groups’ managers and supervisors to ensure day-to-day testing operations are performed. Maintains rigorous quality mindset and advocates strict adherence to compliance practices within the department. Possesses rigorous scientific skills in the specific science area and a strong working knowledge of the technical and Good Laboratory Practice (GLP) / current Good Manufacturing Practice (cGMP) compliance requirements for biosafety testing. Provides a strategic direction for the development of the Viral Clearance operations business. Remains current regarding biosafety testing requirements and develops / modifies assays to fully address such issues. Remains current in the scientific areas of Viral Clearance, Virology and Cell Biology. Prepares study protocols and Standard Operating Procedures (SOPs), assists in preparing new client protocols and revises documents as needed. Works with Sales and Marketing teams to develop the Viral Clearance business including customer site visits, strategic planning and budget development.

Performs any basic to complex Analytical assay(s) 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). Completes Test Methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision. 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. Performs and thoroughly documents Research & Development activities as required.

Performs basic and next-level Analytical 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). Completes Test Methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs and thoroughly documents Research & Development activities as required. Performs daily work activities with minimal supervision.

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 for selected assays

WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network.

STA Pharmaceuticals, a WuXi AppTec Company, has an exciting opportunity for an Associate Director, US Project Management.  This position will be responsible for managing projects within STA, WuXi’s API development and manufacturing division.  Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team.  The incumbent will also participate in business development activities such as visiting existing or new clients and promoting STA’s services in conferences/trade shows.

STA Pharmaceuticals, a WuXi AppTec Company, has an exciting opportunity for an Associate Director, US Project Management.  This position will be responsible for managing projects within STA, WuXi’s API development and manufacturing division.  Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team.  The incumbent will also participate in business development activities such as visiting existing or new clients and promoting STA’s services in conferences/trade shows.

Manage department employees, resources and programs to ensure compliance with all regulatory requirements; specifically ISO 17025, ISO 13485, Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR), Good Laboratory Practices (GLP), Good Tissue Practices (GTP) and relevant foreign regulatory QMS requirements for biopharmaceuticals. Manage all processes of QMS compliance-critical functions for the sites and review related documentation. Monitor, trend and report on aspects of the Quality Systems by working within the department and with other departments to manage the Quality Systems, including management review.  Identify, implement and drive quality improvement projects and policies to reflect industry best practices.

Associate responsible for performing activities within the process development area to develop early and late-stage clinical as well as commercial Cell and Gene Therapy manufacturing processes. Contributes to the overall operations of the process development team, with a focus on technical execution in the development laboratories as well as maintenance of the laboratories and laboratory quality systems. Contributes to the achievement of company and departmental goals and objectives.

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).