Description

COMPANY : Legend Biotech USA, Inc.

JOB TITLE : Investigations Supervisor

JOB DUTIES :

1. Support area Manager and work closely with investigators to ensure investigations are completed on time and as per guidelines.
2. Assign investigations to team members and track them to completion
3. Follow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.
4. Perform investigations and train new investigators.
5. Collaborate with team to determine if corrective actions adequately addressed root cause of NC event.
6. Support tracking of deviations, events and key process parameters and provides reports to management on trending, and status as requested.
7. Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
8. Implement process improvements within the change control system.
9. Recognize and act on potential compliance issues and opportunities for process changes/improvement.
10. Partner with all stakeholders to implement process improvements.
11. Assure regulatory compliance and technical feasibility of proposed changes.
12. Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
13. Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
14. Maintains various databases of production information.
15. 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).
16. Review and approve SOP and Batch record revisions.

MINIMUM JOB REQUIREMENTS:

Education: Bachelor's degree in Engineering, Science, or a related field.

Experience: 3 years as a Lead Engineer

Special Skills: Operate eLIMS, TrackWise, Maximo, EMS, BMS, and SAP systems

JOB SITE : 1000 US-202, Raritan, NJ 08869

WORK HOURS : 9:00 a.m. to 5:00 p.m. 5 days 40 hr/wk

SALARY : $143,796.12 /yr.

TO APPLY : E-Mail CV to [email protected]

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.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

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.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice .