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Le Superviseur Bulk Operations aura pour mission d’assurer les activités de fabrication des produits (capsules et (ou) comprimés), dans le respect de la réglementation BPF/ cGMPs, des règles d’hygiène, et de sécurité. Il devra s’assurer du respect du plan de production établi tout en se conformant aux procédures définies par le système qualité du site pharmaceutique.
Le Technician Bulk Operations aura pour mission d’assurer les activités de fabrication des produits (capsules ou comprimés), dans le respect de la réglementation BPF / cGMPs, des règles d’hygiène, et de sécurité. Il devra se conformer aux procédures définies par le système qualité du site pharmaceutique.
Supervises the day-to-day viral clearance operations (employees, resources, and capacity) to ensure execution of testing support services. Oversees the performance of the team to perform routine adventitious virus testing 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). Holds the team accountable to operational and performance metrics. Strong technical understanding of cell culture processes. Acts as Study Director and/or training coordinator as required.
Performs Cell Culture, qPCR and Cell-Based assays (BSL2 and BSL2+) 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 batch records and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Sufficiently competent in science and may serve as a Qualified Trainer as needed. May have client-facing interaction.
Responsible for leading multiple software projects along with internal technology enhancements. The individual is responsible for identifying, planning and managing all project milestones. This position supports internal customer deliverables across the entire organization with a heavy focus on SDLC process.
This Scientist role will be part of an innovative Medicinal Chemistry group, with responsibilities including (but not limited to) the synthesis and purification of novel compounds for potential clinical drug development, including opportunity to work within WuXi AppTec and different capability departments. The Scientist will work independently in planning and executing multi-step synthetic sequences on small and large scale. The Scientist should also be familiar with modern chromatographic and analytical techniques, including flash chromatography, HPLC, LCMS and NMR. The Scientist should also demonstrate strong desire to work in multi-disciplinary teams, learn new skills and proactively solve problems. Additional responsibilities include, but are not limited to: regularly communicate progress and strategy to clients and internal teams and supervise research associates.
This Associate Director role will be part of an innovative Medicinal Chemistry group, with responsibilities including (but not limited to) the design, synthesis, and purification of novel compounds for potential clinical drug development, including opportunity to work within WuXi AppTec and different capability departments. The Associate Director will typically manage a large medicinal chemistry or diverse functional team of research scientists and associates within a collaborative environment, and be responsible for providing motivating professional development guidance and/or coaching of colleagues within his/her group, as well as others. Additional responsibilities include, but are not limited to: independently devise and implement creative scientific strategies to address complex drug discovery issues through direct reports and a larger team, determine team direction to advance programs, regularly communicate progress and strategy to clients and internal teams. The Associate Director will serve as a scientific resource to the department and broader organization who will champion new technologies/ideas to enhance capabilities and train future leaders in medicinal chemistry.
The Product Manager leads the delivery of WuXi’s offering of specific products. A product is defined as the service that WuXi provides for delivery of a finished good to a patient. The products range from a manufacturing process to lot release testing. The Product Manager is responsible for overseeing a portfolio of Client specific products and aligning with the assigned Project or Commercial Manager to meet the Client’s goals.
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.
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 Senior Clinical Project Manager - Oncology manages and coordinates clinical project services for sponsors to assure project/program milestones are met according to contract and applicable regulations are followed.
Job Location: Flexible to be based in any location in the U.S.
Job Summary: With supervision serve as study director/principal investigator to perform MD, MV/MQ and Sample analysis for Large Molecule (LM) Bioanalysis projects. Troubleshoots Wet Lab LM Bioanalysis assays issues and assist in training of LM analysts on wet lab LM systems. Can communicate; write responses to QC/QA findings. Communicate with Clients on specific projects that they are responsible. Accountable for accurate data submission and on time delivery of assigned projects.
This position will perform a variety of routine analytical chemistry analysis. The position will also include performing or providing mentorship on a variety of sample preparations/extractions/leaching and standards and reagent preparation, as needed.
The work schedule for this role is either Sunday-Thursday or Tuesday - Saturday
Job Summary: Plans and carries out in vivo experiments and associated research assignments in rodents. Maintains the vivarium, labs, and program to AAALAC standards. Operates lab equipment including oxidizers, centrifuges, LS counters, and cage/tunnel washers.
WuXi AppTec Laboratory Testing Division’s International Marketing Team is looking for a 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 marketing plans for the services driving our business. The Product manager will be responsible for developing, initiating, creating and executing an annual 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 managing services or product lines by 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.
The Manager, Data Management is responsible for oversight of clinical data management
functions on assigned projects and department line management.
This individual will be responsible for performing the technical aspects of assigned tests in compliance with GLP, USDA and AAALAC guidelines.
Please note the work schedule for this role is Sunday-Thursday, 7 am - 3:30 pm
The successful candidate will play a key leadership role in building and managing the integrated discovery programs, and leading a team of internal & external partners working on discovery programs. The person will also represent medicinal chemistry on cross-functional teams involved in developing strategy, assessing and making go/no-go decisions.
DEL (DNA-encoded library) is a rapidly growing drug discovery platform at HitS Business Unit in WuXi AppTec. This cutting-edge multidisciplinary platform combines the latest technologies in chemistry, chemical biology, biology and informatics. We are seeking for highly motivated and enthusiastic intern to join this platform. The candidate will collaborate closely with other functional teams in maintaining and developing our data platform, developing data-based applications and participating in data analysis and reporting.
The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for STA Pharmaceutical, a WuXi AppTec company, in particular to support the growth of emerging oligo and peptide (O&P) Contract Development and Manufacture (CDMO) business. The candidate will work closely together with the U.S. and Europe business development (BD) teams to pursue new business leads; follows up on critical issues and aides in resolving customer inquiries. Assists marketing in delivering content and driving success of new and existing services.
Job Summary: The Senior Clinical Research Associate - Oncology is a critical position within the Operations team and is assigned as a study lead to manage clinical trial studies. The Senior CRA will partner with a Project Manager to support activities on complex/larger trials and will work collaboratively with internal and external team members supporting project team activities and ensuring all study deliverables are completed on time and within budget. The Senior CRA will work to manage, oversee and may monitor/co-monitor clinical trial sites.