L

Legend Biotech

Develops and commercializes cell therapies

R&D Applications Specialist

Enterprise ApplicationsConfirmed live in the last 24 hours
Full-timeSomerset County, NJ, USA

About the Job

Requirements

  • A Bachelor of Science degree and 3–5 years of experience in the biotechnology or pharmaceutical industry are required.
  • Understanding of laboratory science in the life sciences industry is required; experience in cell therapy is preferred.
  • Understanding of GxP software administration and configuration is required.
  • Experience installing, configuring, and supporting systems and applications in laboratory environments is required.
  • Experience with direct customer or user interaction, including training, is required.
  • Ability to support and improve the laboratory computing environment while following standards is required.
  • Experience supporting standalone or enterprise computerized systems and/or applications is required.
  • Problem-solving skills are required.
  • Ability to work on multiple complex projects, take independent action, and develop recommendations to resolve problems is required.
  • Ability to prioritize objectives across multiple tasks, meet scheduled timelines while remaining flexible, and work independently or as part of a team is required.
  • Familiarity with ticketing systems such as ServiceNow, Jira, or similar is required.
  • Knowledge of the software development lifecycle and computer systems validation is required.
  • Proficient knowledge of Microsoft Office applications, including Access, Excel, Project, PowerPoint, SharePoint, Teams, and Word, and/or other relevant software programs is required.
  • AI literacy is required, including working knowledge of AI technologies and approved AI tools, responsible use to enhance productivity and decision-making, appropriate human oversight of AI-generated outputs, and compliance with organizational AI policies.
  • Strong interpersonal, oral, and written communication skills and a service-oriented attitude are required.
  • Commitment to quality and contribution to a collaborative, positive, team-based environment with a clear purpose and commitment to business goals are required.

Responsibilities

  • Administer and maintain the Equipment/Asset Platform (Blue Mountain RAM), LIMS/ELN (LabVantage), and other laboratory applications used in R&D.
  • Configure and enhance Blue Mountain RAM according to business requirements, maintain and support the system, and ensure compliance.
  • Configure and develop enhancements to the LabVantage LIMS/ELN system according to business requirements.
  • Create and maintain master and static data in laboratory systems through the appropriate change-management process to support laboratory testing activities and meet business, project, investigation, and CAPA timelines.
  • Review method and specification changes and work with appropriate subject matter experts to assess their impact on laboratory-system data setup.
  • Troubleshoot and provide technical support for instrument software installed on laboratory computers and connectivity between computers and instruments.
  • Provision user accounts on standalone and networked equipment and instruments, and on scientific software such as FlowJo, Zageno, and SnapGene, and journal subscriptions.
  • Collaborate with laboratory, manufacturing, analytical support, and site or global IT teams to ensure system needs and requirements are accurate.
  • Assist colleagues with assigned work activities and deliverables to support timely and effective execution of team responsibilities.
  • Test changes and enhancements through dry runs, system testing, and user acceptance testing.
  • Evaluate, recommend, and implement processes to improve compliance and laboratory-testing efficiency, including visibility into testing queues and monitoring testing metrics, to support product release, new products, and key performance indicators and lean-lab metrics.
  • Execute and document change control, and verify changes executed by team members for accuracy.
  • Author, revise, and review procedural documents such as standard operating procedures and work instructions, and contribute to associated training content.
  • Support internal compliance and regulatory agency inspections as required.
  • Respond to system issues and troubleshoot to identify root causes.
  • Support and manage R&D applications and the laboratory computing environment in accordance with IT policies and procedures.
  • Coordinate risk assessments and qualification protocols to support the GxP applicability of systems.
  • Track, document, and update incidents and requests accurately in the IT service management system.
  • Assist in updating knowledge-base articles.
  • Participate in training activities and learn new skills, processes, and technologies as directed to support individual and team success.

Desired Qualifications

  • Cell therapy experience is preferred.

About the Company

Legend Biotech

Develops and commercializes cell therapies

Legend Biotech develops and commercializes cell therapies for serious diseases, especially hematological cancers and solid tumors, using multiple technology platforms. Its CAR-T therapies modify a patient’s own T cells to fight cancer, and the company licenses and sells these therapies while pursuing additional research. By pursuing a technology-agnostic pipeline, Legend Biotech aims to bring effective, personalized treatments to patients globally. The company also maintains investor communications to share progress and results.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Bridgewater Township, New Jersey
Founded
2014

Recently Posted Jobs

Explore more opportunities at Legend Biotech

See more jobs