Investigations Supervisor
About The Position
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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. 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). 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 myeloma.
Requirements
- Bachelor’s degree in Engineering, Science, or a related field.
- 3 years as a Lead Engineer
- Operate eLIMS, TrackWise, Maximo, EMS, BMS, and SAP systems
Responsibilities
- Support area Manager and work closely with investigators to ensure investigations are completed on time and as per guidelines.
- Assign investigations to team members and track them to completion
- Follow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.
- Perform investigations and train new investigators.
- Collaborate with team to determine if corrective actions adequately addressed root cause of NC event.
- Support tracking of deviations, events and key process parameters and provides reports to management on trending, and status as requested.
- Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
- Implement process improvements within the change control system.
- Recognize and act on potential compliance issues and opportunities for process changes/improvement.
- Partner with all stakeholders to implement process improvements.
- Assure regulatory compliance and technical feasibility of proposed changes.
- Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
- Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
- Maintains various databases of production information.
- Support coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).
- Review and approve SOP and Batch record revisions.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave after just three (3) months of employment
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
- Flexible spending accounts
- Health savings accounts
- Life and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
- Commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
