Quality Person In Plant

Hiring By - Biostaffic

 BioPharma

Belgium

Job Highlights

Not Disclosed

Entry level

Posted 4 months ago
Job details
Company Information
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 Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview:
The Quality person in plant is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. Job duties are performed within a team according to an assigned, production shift schedule. This role will work in shift regimes supporting the 7/7 days cell processing.
Major Responsibilities:
  • Serves as a Quality person in plant in support of cell therapy manufacturing.
  • Ensures Quality Oversight in plant covering various process related activities
  • Performs periodic Quality checks/audits related to process, documentation and process manipulations
  • Strive to reduce non-conformances and deviations in supported areas by proactively driving compliance.
  • Responsible for real time review of process documentation in support of process unit operations and release activities where needed.
  • Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
  • Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints.
  • Review and approve manufacturing procedures and batch records
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Support regulatory inspections and audits by ensuring inspection readiness within facility.
  • Perform internal housekeeping audits.
  • Other duties will be assigned, as necessary.
Qualifications
Education:
A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry.
Experience:
A minimum of 2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of experience with quality support in clinical manufacture is preferred.
Key Capabilities, Knowledge, and Skills:
  • Aseptic processing in ISO 5 clean room and biosafety cabinets.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
  • Great attention to detail and ability to follow the procedures.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
  • Good written and verbal communication skills are required.
  • Ability to summarize and present results, and experience with team-based collaborations is a must.
  • Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
  • Must exhibit strong leadership skills and effectively develop others.
  • Ability to collaborate well with stakeholders, customers and peers.
  • Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
  • Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
  • Ability to manage conflict and issues that arise with internal or external customers.
  • Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
Language Requirements
Dutch and technical English
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 law.
Legend Biotech maintains a drug-free workplace.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Belgium

Experience:

  • Entry level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 16, 2024
Company Overview
Legend Biotech
Legend Biotech

Current Openings: 0

Legend Biotech is a global, commercial-stage biotechnology company developing and manufacturing novel therapies. We explore and apply innovative technologies to deliver cutting-edge options for patients around the world. Our corporate headquarters is located in Somerset, NJ, and our manufacturing footprint includes facilities in the United States, China and the Belgium.
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