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Be Qc
il y a 2 semaines
**Company Information**
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.
**Role Overview**:
The
** QC / EMS Analyst **is a 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.
**Major Responsibilities**:
QC
- Responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
- Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
- Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
- Conduct testing of in-process samples submitted to the QC laboratories.
- Perform peer review/approval of laboratory data.
- Utilize electronic systems (LIMS) for execution and documentation of testing.
- Create, review and approve relevant QC documents, SOP's and WI's.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
EMS
- Serves as a Quality person in plant in support of cell therapy manufacturing.
- Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
- Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
- Review and approve manufacturing procedures and batch records
- Real time review of all documentation and reporting in support of process unit operations and release activities.
- Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- 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.
**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**:
**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.-
- 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.- Fluency in Dutch and English
LI-MJ1
**Legend Core Behaviors**
Ownership and Commitment
- Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
- Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
- Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.
Agility and Prioritization
- Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
- Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
- Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
- Employs good project management principles to appropriately align time, resources, and budgets.
Teamwork and Communication
- Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.
- Articulates ideas clearly and succinctly in a variety of settings and style
