Sobre este puesto de R&D Applications Specialist en Legend Biotech US
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.
Legend Biotech is seeking an R&D Applications Specialist as part of the Information Technology team based in Somerset, NJ.
Role Overview
The R&D Applications Specialist will assist in the operation of laboratory IT capabilities and R&D systems. This individual’s responsibility will include operation maintenance and implementation/development of enhancements of applications that are used in the R&D laboratories.
Key Responsibilities
- Administrating and maintaining Equipment/Asset Platform (Blue Mountain RAM), LIMS/ELN (Labvantage) and various other lab applications used in R&D.
- Configure/enhance BMRAM as per business requirements. Maintain and support the system and ensure that it is compliant.
- Configure/develop enhancements to LabVantage LIMS/ELN system as per business requirements. Create and maintain master data/static data in lab systems by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met. Review method/specification changes and work with appropriate SMEs to assess impact to lab systems data set up.
- Aid in troubleshooting and assist in technical support of both instrument software installed on lab computers and connectivity between computer and instrument.
- User account provisioning on stand-alone and networked equipment and instruments.
- User account provisioning on scientific software (e.g., FlowJo, Zageno, SnapGene, Journal Subscriptions, etc.).
- Collaborate/liase with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the systems.
- Contribute to team success by assisting colleagues with assigned work activities and deliverables, ensuring timely and effective execution of team responsibilities.
- Test changes/enhancements through dry runs, system test and user acceptance test.
- Evaluate, recommend and implement processes to improve compliance and the efficiency of laboratory testing operations (i.e visibility to testing queues, testing metrics monitoring, etc) to support product release, new products, and key performance indicators/lean lab metrics.
- Execute and document appropriate change control and/or verify changes executed by team members are accurate.
- Author, revise, and/or review procedural documents, such as SOP sand WIs and contribute to the development of associated training content.
- Provide support for internal compliance and regulatory agency inspections as required.
- Respond to system issues and troubleshoot to identify root cause.
- Provide support and systems management of R&D applications and lab computing environment in accordance with IT Policies and Procedures.
- Coordinate the necessary risk assessment and qualification protocols to support the GxP applicability of systems
- Track, document, and update incidents and requests accurately in the IT Service Management (ITSM) system
- Assist in updating any knowledge base articles.
- Maintain a willingness to learn new skills, processes, and technologies, and participate in training activities as directed to support individual and team success.
Requirements
- BS degree with 3-5 years experience in Biotech/Pharmaceutical industry.
- An understanding of laboratory science in the life sciences industry, preferably in cell therapy space.
- Understanding of GxP software administration and configuration.
- Installing, configuring and supporting systems and applications in lab environments.
- Experience with direct customer/user interaction, including training.
- Demonstrate an understanding of the need for standards yet also have a willingness to look for new, more effective strategies to support and improve the laboratory computing environment.
- Experience supporting standalone or enterprise computerized systems and/or applications.
- Commitment to Quality.
- Problem solving skills.
- Ability to work on multiple complex projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations
- Demand Management Skills - Ability to take initiative and prioritize objectives from multiple tasks; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team. Self-directed with a high degree of professional integrity, very organized, and detail oriented.
- Familiarity with ticketing systems (ServiceNow, Jira, or similar)..
- Must have knowledge of software development lifecycle (SDLC) and of computer systems validation (CSV)
- Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs.
- Strong interpersonal, oral and written communication skills, and service-oriented attitude are essential. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
#Li-FB1
#Li-Hybrid
The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.
Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
Work Authorization & Employment Eligibility
Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
