Be Qc Analyst

il y a 1 jour


Gent, Belgique Legend Biotech Temps plein

**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.

**Position Overview**

The QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

**Major Responsibilities**
- 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 analytical testing of raw material/utility, in-process, or final product 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.

**Key Relationships**

Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations and Analytical/Process Development.

**Qualification**

**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**:

- Experience in a Quality Control setting is preferred.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
- Knowledge of Good Tissue Practices is required.
- Detailed knowledge of CAR-T QC test methods and related equipment is preferred
- Excellent written and oral communication skill are required
- Comfortable with speaking and interacting with inspectors.
- This position may require occasional travel to partner sites in NJ or PA as business demands.
- This position may require up to 10% domestic or international travel as business demands.

**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 styles; can get messages across that have the desired effect.
- Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.
- Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.
- Continuous Improvement
- Actively pursues and shares knowledge, builds skills, promotes new ideas and embraces change.
- Generates new solutions to problems by challenging the status quo and conventional thinking.

Legend Biotech maintains a drug-free workplace.


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