WuXi AppTec

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Job Locations US
Hybrid Role/Remote   Job Summary: The Senior Director, Clinical Operations – Oncology will manage multiple global clinical trials of moderate to high complexity.  They will manage all aspects of the global clinical studies Phase I through Phase IV and for various therapeutic areas with an emphasis in Oncology.  This position could be required to travel about 25-30% of the time both domestically and internationally.   Essential Job Functions: - Provides operational supportfor Clinical Operations and Data Management and is an advisor in Oncology for the team. - Accountable for strategy, clinical trial execution, timelines, resource planning, budget forecasting and management. - Serves as senior project interface with clients in role of senior project manager or project advisor. - Serves as primary clinical operations contact for proposal development, proposal defense, and other business development responsibilities as required. - Ensure activities are conducted in accordance with WuXi, ICH, and GCP standards. - Leading cross-functional teams to provide high quality and timely execution of deliverables and overall trial service to the customer. - Develop and maintain strong, collaborative relationships with key stakeholders inside and outside the organization. - Ensures maintenance of corporate systems by collection of data to be included in the metrics database, sponsor database, investigator database, and protocols database. - Evaluates and recommends opportunities for new service offerings through organic and acquisitional growth. - Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested. - Assists with development of clinical protocols and SOP’s. - Ability to work in a team environment and independently as required. - May be required to work Holidays and weekends. - Contributes to the overall operations and to the achievement of departmental goals - Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures. - Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations [List as appropriate and could also go under KSA’s below] - Other duties as assigned - May be required to assist in other departments              Job Requirements   Experience / Education:            - Should have a minimum of 10 years clinical research experience in CRO, pharma, biotech/device company with ____ years of Oncology, 8 years of directly related project management experience, and 5 years of supervisory experience of clinical and data project professional level individuals required.     - Solid experience in hematology indications preferred - Understanding of Oncology therapies and practice as it relates to clinical trial design - Experience in leading clinical and data project teams from study startup through clinical/statistical reports. - Must demonstrate advanced knowledge of clinical, regulatory, and data aspects of trials including, but not limited to FDA review processes, IND and NDA processes, GCP’s, field monitoring, data management, biostatistics, and medical writing. - Advanced degree preferred. Bachelor’s degree or commensurate experience required.   Knowledge / Skills / Abilities:   - Requires minimal supervision - Superior problem solving skills involving considerations of time, financial, quality, and customer relations - Is expected to apply decisions from previous discussion to new situations independently - Expected to require minimal supervision on operational decisions that can have substantial impact on company, infrastructure, or policies - Requires excellent verbal and writing skills to communicate with team, sites, and clients and be an active listener - Ability to effectively communicate in issues and to autonomously implement resolutions to team members - Must show excellent interpersonal communication skills and exhibit ability to lead team using appropriate motivational skills, conflict management, and integrity - Must exhibit positive, professional demeanor in all communications and must be able to introduce differing communication strategies to solve issues at the team and sponsor level - Must have excellent organizational and negotiation skills - Expected to have good working knowledge of physician care in hospitals, clinics, or other healthcare settings - Must have advanced knowledge of FDA, ICH, and GCP guidelines; excellent project management skills including client management, fiscal management, and quality management; strong time management skills; and ability to thrive in stressful environment with multiple priorities - Must have high level of attention to detail and must have ability to deal professionally with team members, investigational sites, and clients - Must have solid knowledge of computers and Microsoft Office Suite of products - Must have strong management skills including ability to hire, coach/counsel, and terminate employees - Must be able to create career plans and monitor progress - Must have ability to analyze resource usage with available tools - Travel is required 25-30% , Domestic/International, Daily / Overnight   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 - Must be able to travel for long distances in various methods of transportation (i.e. car, airplane, shuttle bus, etc.) - Must be able to navigate to and from client locations, hotel, and airports with personal luggage and laptop.               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.   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.
Job Locations US-NJ-Plainsboro
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 Scientist I within our Bioanalytical Group located in Plainsboro, NJ.   
External ID
WXXBL-14757
Job Locations US-NJ-Plainsboro
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.   
External ID
WXXBL-14756
Job Locations US-NJ-Plainsboro
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 Scientist I within our Bioanalytical Group located in Plainsboro, NJ.     
External ID
WXXBL-14755
Job Locations US-NJ-Plainsboro
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 Scientist I within our Bioanalytical Group located in Plainsboro, NJ.   
External ID
WXXBL-14754
Job Locations US-PA-Philadelphia
Responsible for QC / Environmental operations, which includes implementing and maintaining appropriate environmental sampling and microbiology testing systems; supervising, training and evaluating personnel; analyzing and interpreting monitoring results; and making appropriate decisions and recommendations to address trends, issues or significant observations. Demonstrates leadership in a fast-paced manufacturing setting and operates with minimal oversight and a clear understanding of business and regulatory demands. Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of biopharmaceutical manufacturing environmental monitoring and testing, and excellent understanding of current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) compliance requirements. Efficiently manages staff and other resources to address scientific, business and regulatory needs in an effective and timely manner. Remains current regarding best practices in environmental monitoring and testing and develops or modifies procedures to stay fully compliant with the evolving expectations of all stakeholders. Formulates strategies for routine monitoring and microbiology testing, prepares protocols and standard operating procedures (SOPs), and reviews and approves work of subordinates. Conducts, schedules and directs monitoring and testing activities, keeping appropriate records consistent with regulatory guidance, business needs and client expectations. Gathers and collates results of environmental testing, identifies trends, interprets implications, and recommends procedural changes to drive improvement. Communicates with Management, Quality Assurance and others as appropriate. Participates in development and implementation of validation plans and protocols. Effectively assists with client and regulatory interactions as appropriate.
External ID
WXATU-3266
Job Locations US-MN-St. Paul
Job Summary: This individual will be responsible for performing the technical aspects of assigned tests in compliance with GLP, USDA and AAALAC guidelines.
External ID
WXINC-23489
Job Locations US-MA-Natick
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, enthusiastic, multidisciplinary scientists to join this platform. The candidate will collaborate closely with other functional teams in planning, executing and delivering high quality DEL screening projects to the client.
External ID
WXLLC-12551
Job Locations US-PA-Philadelphia
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.
External ID
WXATU-2386
Job Locations US-CA-San Diego
STA Pharmaceuticals US LLC, a WuXi AppTec Company, is a contract development and manufacturing organization focused on providing high-quality process development, R&D, GLP Tox lots and up to P1/ P2 GMP small molecule manufacturing services to the biopharmaceutical industry.  
External ID
WXSTA-11258
Job Locations US-PA-Philadelphia
Responsible for generating and/or review manufacturing related technical documents and manage timely closure of these documents. This includes but is not limited to Non-Conforming Event (NCE) investigations, CAPAs, Change Controls (CC), Batch Records (BR), Technical Transfers (TT), Final Reports (FR), and Standard Operating Procedures (SOP).
External ID
WXATU-3261
Job Locations US-PA-Philadelphia
The Facilities Technical Operations Specialist will generate and/or review Facilities related technical documents and manage timely closure of these documents. This includes but is not limited to Non-Conforming Event (NCE) investigations, Deviations, CAPAs and Change Controls (CC). The Facilities Technical Operations Specialist will also assist with the generation and maintenance of facilities related standard operating procedures (SOPs).
External ID
WXATU-1904
Job Locations US-PA-Philadelphia
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
External ID
WXATU-3260
Job Locations US-GA-Marietta, Georgia
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.
External ID
WXINC-20402
Job Locations US-PA-Philadelphia
Performs assays according to testing records 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. Serve as the departmental trainer, as needed
External ID
WXATU-2574
Job Locations US-PA-Philadelphia
The Validation Specialist serves as the primary resource for development, execution, review, and approval of equipment qualification (including TCUs, laboratory equipment, computerized systems), change controls. This position will help monitor equipment/software processes for adherence to established procedures/regulatory compliance. Also provide assistance for equipment/software related issues and consults with Validation and Quality Assurance to resolve complex quality issues.
External ID
WXATU-2359
Job Locations US-PA-Philadelphia
Designs, supervise, and interprets research & development and GMP studies as part of Testing Operations. 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 client / inter-department and Testing Operations. Serves as Testing Operations lead on manufacturing core teams for low complexity programs. Authors technical documents, procedures, policies, SOPs, & risk assessments, as needed.
External ID
WXATU-1417
Job Locations US-NJ-Plainsboro
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 III within our Bioanalytical Group located in Plainsboro, NJ. 
External ID
WXXBL-14728
Job Locations US-NJ-Cranbury
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 Scientist I to support the Preclinical department  at our Cranbury, NJ site location.
External ID
WXXBL-14753
Job Locations US-MN-St. Paul
This position performs a variety of administrative and clerical tasks. Duties of the Business Support Administrator include providing support to our managers and employees, assisting in daily office needs and managing the Chemistry department’s general administrative activities.
External ID
WXINC-23475

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