GxP Application Support Lead
Company: Legend Biotech
Posted on: January 27, 2023
Legend Biotech is a global biotechnology company dedicated to
treating, and one day curing, life-threatening diseases.
Headquartered in Somerset, New Jersey, we are developing advanced
cell therapies across a diverse array of technology platforms,
including autologous and allogenic chimeric antigen receptor T-cell
and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with
Janssen, one of the pharmaceutical companies of Johnson & Johnson,
to jointly develop and commercialize ciltacabtagene autolecuel
(cilta-cel) in 2017. Our strategic partnership is designed to
combine the strengths and expertise of both companies to advance
the promise of an immunotherapy in the treatment of multiple
Legend Biotech is seeking GxP Application Support Lead as part of
the US IT team based in Somerset, NJ.
The GxP Application Support Lead will be responsible for leading
and maintaining GxP applications used in pre-clinical, clinical,
and commercial manufacturing.
- Accountable for the controlled production support and life
cycle management for multiple Cell Therapy Development (CTD)
applications used by R&D, Technical Development, and Technical
- Accountable for managing day to day operational support,
enabling the business to scale while improving key performance
indicators impacting their efficiencies and improving overall
- Ensure ongoing compliance with regulatory safety, GMP and
Validation requirements. Ensure all systems are designed, built and
operated to full SDLC requirements.
- Assist with the development and maintenance of standard
operating procedures, work instructions, user guides, and other
relevant documentation; provide technical consulting and perform
user training with Business Systems Owners as needed.
- Assist with change control impact assessments for GxP systems
- Provide Tier 1-2 IT operational support for GxP
- Manage and troubleshoot laboratory software with vendor
support, as needed.
- Consult with Quality and IT Management to resolve complex
issues in a timely manner.
- Coordinate with and manage vendors to ensure the latest
software versions are compatible with systems.
- Minimum of a Bachelor's Degree in a relevant discipline such as
IT or Engineering is required, advanced degree is preferred.
- Minimum 5 year's relevant working experience in biotech and/or
- Knowledge of cell therapy applications in manufacturing
- Excellent written and verbal communication skills
- Ability to perform in a fast-paced working environment
- Experience with SAP, CMMS, MES, LIMS, QMS (Veeva, Documentum,
- Solid understanding of interfaces between MES, LIMS and
- Troubleshoot and defects resolution during validation related
to integration and post go-live issue
- Hands-on experience with pharma project execution
(requirements, analysis, design definition, design review, solution
implementation, testing and acceptance, traceability).
- Knowledge of FDA and GMP guidelines
Legend Biotech is a proud equal opportunity/affirmative action
employer committed to attracting, retaining, and maximizing the
performance of a diverse and inclusive workforce. It is Legend's
policy to ensure equal employment opportunity without
discrimination or harassment based on race, color, religion, sex
(including pregnancy, childbirth, or related medical conditions),
sexual orientation, gender identity or expression, age, disability,
national origin, marital or domestic/civil partnership status,
genetic information, citizenship status, uniformed service member
or veteran status, or any other characteristic protected by
Legend Biotech maintains a drug-free workplace.
Keywords: Legend Biotech, Trenton , GxP Application Support Lead, Other , Somerset, New Jersey
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