工作内容
The Product Lifecycle Scientist is responsible for preparing, designing and implementing plans for the characterization, validation or lifecycle of commercial processes according to Regulatory Authorities guidances. He/She works closely with relevant R&D, QA, QC, GMP Manufacturing representative and reports to the Product Lifecycle Lead.
Roles and responsibilities:
- By working closely with all relevant internal stakeholders (R&D, QA, QC, GMP Manufacturing) and customers:
- Build strong product knowledge and associated process-related risk or gap assessments to prepare for characterization and validation activities.
- Define activities and plans relevant to process characterization and validation
- Define and evaluate parameters and outputs, with their ranges and classifications for a specific process
- Design validation supportive studies such as hold times, stability, cleaning, bacterial challenge test, media fill test, container integrity test, mixing and homogeneity, extractible & leachable, viral clearance
- Design the Continued Process Verification and identify appropriate solutions for process monitoring (trends, deviations, process outputs)
- Provide well-written, accurate and timely protocols, reports relevant to these activities
- Provide on-site support to the R&D and GMP units during the implementation and execution of characterization and validation campaign
- Provide support during regulatory inspections, VMP or Annual Quality Reviews activities, acting as the process lifecycle representative
Required Qualifications
Master degree in a life sciences or Chemical Engineering discipline
Minimum of 3 years of relevant experience in Process characterization, validation and life cycle management for biologics, vaccines or cell/gene. Demonstrated knowledge in some of the following fields applied to viral vectors: upstream/downstream/drug product process, cell culture, chromatography, filtration, raw material management
Knowledge in biostatistics and analytical methods
Ability to work cross-boundaries
Excellent written and verbal communication skills
Language skills: French and English
最后期限: 31-12-2025
点击免费申请候选人
报告工作
相同的工作
-
⏰ 21-12-2025🌏 Mouscron, Hainaut
-
⏰ 23-12-2025🌏 Charleroi, Hainaut
-
⏰ 05-01-2026🌏 La Louvière, Hainaut
-
⏰ 05-01-2026🌏 Enghien, Hainaut
-
⏰ 22-12-2025🌏 Charleroi, Hainaut
-
⏰ 05-01-2026🌏 Charleroi, Hainaut
-
⏰ 23-12-2025🌏 Comines-Warneton, Hainaut
-
⏰ 18-12-2025🌏 Chièvres, Hainaut
-
⏰ 22-12-2025🌏 Mouscron, Hainaut
-
⏰ 17-12-2025🌏 Mons, Hainaut