Role Overview
The CAR-T Senior Process Engineer will be part of the MSAT team and will be responsible for:
1. Participating in the design and implementation of Process Validation / Engineering activities to support the Strategic Plan.
2. Providing scientific knowledge and cGMP expertise in cell and gene therapy processes and/or process technologies to establish the appropriate holistic Process Control Strategy.
3. Supporting and ensuring cGMP readiness of the product process through an appropriate validation strategy in compliance with regulations, procedures, and the validation master plan.
4. Providing ad hoc scientific support to the Investigation team and bringing knowledge to resolve deviations and atypical events.
Major Responsibilities
The CAR-T Process Engineer reports to the Process Validation/Engineering Lead and is responsible for:
1. Process Robustness (Engineering/Validation)
* Participate in the design and implementation of Process Validation / Engineering activities to support the Strategic Plan.
* Provide support, scientific, and technical expertise in the Technical Operations group, owning the process knowledge of the cell and gene therapy manufacturing process technology to support tech transfer/validation activities into and out of the Ghent facilities.
* Draft and maintain Manufacturing Batch records and related documentation up to date.
* Participate in the establishment and maintenance of the Master Validation Plan related to the manufacturing process.
* Design studies necessary to successfully implement/validate the manufacturing process: draft/review documentation (protocols and reports, flow diagrams, instructions, training) and oversee execution.
* Build knowledge/expertise within the team to define robust Process and Contamination Control strategies, including sterility assurance.
* Draft Process Risk Assessments for the implementation of process changes.
1. Quality & Compliance
* Support and ensure cGMP readiness of the product process through appropriate transfer/validation plan.
* Serve as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
* Provide ad hoc technical/scientific assessment, recommendations, and support to cGMP documentation: Change Controls, deviations, and CAPAs.
* Provide scientific expertise to help identify true root causes of investigations and assess product quality impact.
* Ensure regulatory compliance and technical feasibility of proposed changes.
* Review and approve SOPs and Batch records.
2. Continuous Improvement / Operational Excellence
* Identify opportunities for process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost, and drive implementation aligned with the change control strategy.
* Partner with all relevant teams and/or external vendors to implement process improvements. Work with vendors to evaluate new raw materials and consumables for compatibility with the Manufacturing process.
* Contribute to data collection and trend analysis as requested by QA and Regulatory Affairs, including the annual report for the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).
* Keep up to date on the latest CAR-T product & process updates and liaise with other technical development teams.
Qualifications
Education: A minimum of a Master’s degree in Engineering, Science, Pharmacy, or a related field, or equivalent experience.
Experience: Minimum 3 years of operations experience within a cGMP environment in the biotech/biopharma industry. Cell and Gene Therapy Manufacturing experience is preferred.
Capabilities, Knowledge, and Skills
* Ability to work cross-functionally and successfully.
* High organizational skills: prioritize and manage multiple tasks simultaneously in a fast-paced environment.
* Good communication skills (both written and oral).
* Ability to build strong partnerships and effectively collaborate in a matrixed environment.
* Strong analytical, problem-solving, and critical thinking skills; ability to lead change.
* Self-motivated, enthusiastic, and empathetic.
* Work precisely according to procedures and rules.
* Result-driven.
* Understanding of statistical analysis software like JMP.
Languages
Fluent in Dutch and English.
Legend Biotech is an equal opportunity employer committed to diversity and inclusion. It maintains a drug-free workplace.
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