This role is a mix of administrative and lead generation activities to support the business development objectives of the European and Israel sales team and will provide the successful applicant with the ability to interact with both locally based sales teams and colleagues based overseas in China and US.  

This individual will be responsible for the histology preparation of tissue specimens for microscopic analysis by a pathologist in compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations.

Designs, supervise, and interprets research & development and GMP studies. Provides appropriate resources to team to conduct studies. Supervises team of scientific personnel with varying skill level. Directs and leads team to stay on track to meet project deadlines. Oversees assay transfers between Analytical Development and Testing Operations. Serves as analytical lead on manufacturing core teams for low complexity programs. Interfaces with Sales team regularly. Authors technical documents, procedures, policies, SOPs, & risk assessments, as needed

Oversees the key, core assay development groups within Analytical Development. Responsible for overseeing new method development, assay qualifications and validations, as well as internal and external assay transfers. Partners with Testing Operations management to transfer methods from Analytical Development to Testing Operations. Provides high-level technical support as needed. Manages assay functional leads and supervisors and is responsible for strategical planning, project timelines, appropriate resourcing, setting appropriate goals, and personnel development. Possesses rigorous scientific skills in biologics testing and a strong working knowledge of Good Manufacturing Practice (cGMP) compliance requirements for biologics testing. Remains current regarding regulatory testing requirements and develops / modifies assays in accordance. Remains current in the scientific areas of their respective functional areas and serves as a key subject matter expert to the organization. Engages clients and auditors regularly.

Contribute to the design and execution of BD plans in close coordination with Research Services Division (RSD) leadership for identification, penetration and growth of RSD business and accounts.

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.   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.”

Participates in the execution of chemical processes for the preparation of raw materials, starting materials, intermediates, and API in the Kilo-Lab (Process Room suites) and Pilot Plant in compliance with cGMP regulations (as required). This typically includes acting as lead operator for a given process in the Pilot Plant, but may also include acting as a technical supervisor and may include participating on a process in the Kilo Lab suites. Also responsible for keeping the Pilot Plant equipment and suites functional and compliant, as well as participating in Materials Management.

Responsible for 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).

The position will be responsible for managing the safe execution of chemical processes in the Kilo-Lab (Process Room suites) and Pilot Plant in compliance with cGMP regulations. The candidate will work with a team of operators in conjunction with PR&D and Analytical Chemistry Departments and assist in developing safe, efficient and easily scalable processes for producing raw materials, starting materials, intermediates, and active pharmaceutical ingredients (API’s), along with Powder-in-Capsule (PIC) products. In addition, the candidate will work with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process development and campaign reports including batch production records (MBRs/EBRs) are completed in a timely manner. This position has overall responsibility for keeping the Kilo Lab and Pilot Plant equipment and suites functional and compliant. The ideal candidate will have shown proficiency in hands-on chemical manufacturing and process safety work, the ability to manage activities and solve challenges, extensive experience reviewing and organizing chemical production data and leading a chemical production/engineering team. The position requires a strong background in drug substance production, as well as thorough knowledge of relevant equipment and cGMP, ICH and relevant FDA guidelines. CDMO experience is beneficial.

HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its IO in vitro Division. We’re seeking a full-time Senior Scientist to help advance HD Biosciences’ immuno-oncology team to complete client-based projects and experiments.

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.   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 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 Senior Project Manager  within our Bioanalytical Group located in Plainsboro, NJ. 

WuXi AppTec Pathologists contribute to a wide range of critical activities within Toxicology, Safety, and Biocompatibility. Testing including but not limited to study evaluation for nonclinical studies spanning all phases of drug development for pharmaceutical industries.  This position has the flexibility to be based in Plainsboro, NJ or Cambridge, Massachusetts.

WuXi AppTec Pathologists contribute to a wide range of critical activities within Toxicology, Safety, and Biocompatibility. Testing including but not limited to study evaluation for nonclinical studies spanning all phases of drug development for pharmaceutical industries.  This position has the flexibility to be based in Plainsboro, NJ or Cambridge, Massachusetts; or can be worked remote.

This position within the Project management team (PM) will primarily support the review and generation of quotations of queries for Biology preclinical studies. The candidate should have a biology background, be detailed oriented and well organized. This position requires someone who has a scientific background in target discovery, drug development in various disease areas.

The Quality Control Specialist will interact directly with internal WuXi AppTec customers for disposition of materials following Good Manufacturing Practices (cGMP) documentation. 

  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. 

HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is seeking a highly motivated and exceptional leader as Executive Director to join the leadership team for its Immuno-Oncology and in vivo pharmacology Division. This position will work closely with the VP/Head of the division to provide scientific and operation leadership support, and be responsible for team building, customer engagement, and business goal delivery.

This position within the Project management team (PM) will primarily support the project management team, focusing on documentation, maintenance of the electronic and hard copies of archived data.  Candidate may be asked to help in other functions within the PM team as needed. The candidate should be detailed oriented and well organized. This position requires someone who is a good team player.

  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.