The Senior Quality Assurance (QA) GCP Auditor will support the Quality Management activities at WuXi Clinical San Diego. The Senior QA Auditor will assist with the planning, coordinating, and implementing quality management and quality improvement programs. The Senior QA Auditor will monitor and provide assistance with quality assurance and compliance functions with WuXi Clinical. They will ensure programs and services are implemented at the highest standards.

WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. We’re seeking a Group Leader for our In-Vitro Biology group located in Cranbury, NJ. 

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

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

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

Job Summary: The activities associated with this role fall into two categories: 1. Medicinal chemistry project direction within programmes coordinated by the SPARK team 2. Support the US business development team as required  

The activities associated with this role fall into two categories: 1. Coordination of discovery biology aspects of programmes supported by the SPARK team 2. Support the US business development team as required  

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.

Responsible for providing direct oversight, coaching, mentoring and leadership in the manufacture of biologics products performing activities within production facilities to support manufacture of upstream/ downstream operations according to current Good Manufacturing Practices (cGMPs).

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 Bioanalytical  Group located in Plainsboro, NJ. 

WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. We’re seeking an Scientist/Senior Scientist for our In-Vitro Biology group located in Cranbury, NJ. 

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.

WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations.  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 Scientist II within our Bioanalytical - Small Molecule Group located in Plainsboro, NJ.

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.

The Associate Quality Specialist is responsible for ensuring GLP studies, GMP testing, and GMP manufacturing activities are executed in accordance with the appropriate regulatory bodies and internal procedures.

Job Summary: Responsible for all aspects of assigned standard biocompatibility studies performed within In-Life Services (ILS) at WuXi AppTec in compliance with GLP, ISO, FDA, and any other applicable guidelines. Interfaces between the St. Paul facility and the Sponsor in terms of study planning, organization, staffing, data analysis, final report generation and sponsor communication.

Contract Specialist will be responsible for the review, negotiation and management of customer contracts and will work closely with other Contract Specialists, attorneys, as well as senior management and business professionals within WuXi to facilitate timely review and completion of a high volume of customer contracts with clients, in accordance with WuXi policies and standards. This individual will also interface with outside partners and customers in connection with these contracts.  Contract Specialist will be based in our New Jersey location or will have the capability to work remote. 

Founded in 2000, the WuXi AppTec is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 25,000 employees across 25 locations globally. The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec’s dream that “every drug can be made and every disease can be treated.”   WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.   WuXi Oncology (WXO) engages expert consulting, trial design, and turnkey commercial management execution of global Phase I-III trials from Pre-IND through regulatory approval. The company was launched to meet the pressing demand for hard-to-obtain, oncology-focused, commercial development subject matter and expertise needed for Phase I-III trials in China and the United States. Empowering innovators of the most advanced cancer therapeutics and ensuring that even smaller companies receive the best attention and quality of service – meeting the unique challenges of clinical complexity together. Our philosophy and focus is to “Follow the Molecule” from Bench to Bedside, throughout all phases of clinical development, while keeping innovative breakthrough science intrinsically connected to the patient. We believe every cancer can be treated and cured by the development of new medicines.   Job Summary: The Senior Manager, Proposals & Contracts works independently to ensure proposal deadlines are met with submittal of professional, detailed, and quality proposal text and study budgets.  This will be a fully remote position.     Job Requirements Experience / Education:  - Minimum 5 years of life sciences industry experience required working with clinical operations in proposal writing and managing contracts - Bachelor’s Degree required Knowledge / Skills / Abilities:  - Thorough knowledge of contract and budget preparation and ability to interpret budgets required - Understanding of the clinical process (Phase I - IV) and associated cost drivers required - Must be able to thrive in a deadline-driven environment with multiple priorities - Highly independent, self-starter with an ability to take input from all levels of the BD and Operations teams to create clear and effective proposals - Exceptional communication skills in English, verbally and in writing  - Must have excellent organization skills, writing, communication, and budgeting skills (proficient in MS Office)   Physical Requirements:          - Must be able to work in an office environment, which has minimal noise conditions - Ability to stand or sit for most of the work day - Must be able to perform some activities with repetitive motion, such as keyboarding   An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.    

Founded in 2000, the WuXi AppTec is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 25,000 employees across 25 locations globally. The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec’s dream that “every drug can be made and every disease can be treated.”   WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.   Job Summary: The Clinical Project Associate I provides administrative support to clinical research projects by assisting project teams in the completion of assigned project activities. This is an in-office position with that does not require travel.

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.