QC Microbiology Scientist
Date: Feb 27, 2019
Location: Braine L'alleud, Walloon Brabant, BE
QC Microbiology Scientist
- NCE, NBE, environmental & fluid controls
- From phase I through the life cycle of the product
- Method Development, validation, release and stability testing
The function supports development and validation of all UCB microbio methods including new technology implementation for efficiency increase in QC lab's. The function also include the support for the implementation of new production facilities.
1. The primary goal is to be the microbiology expert to support method development, validation, release and stability testing for NCE and NBE projects from phase I through the life cycle of the product.
2. The function will be the key expert to train technicians to microbio methods and support troubleshooting for any UCB sites, Braine manufacturing and external partners.
3. The function will play a key role in the implementation of new lab technologies and production facilities.
4. The function includes the management of CRO/CMO testing, supporting release and stability testing.
5. The function will support all regulatory aspects related to any microbio activities, and will ensure the interface between the microbio lab and Regulatory Affairs, and insure microbio testing lab being compliant to regulation requirement updates.
6. The function includes development, implementation and supervision of sampling plan for environnemental and utilities controls.
1. Apply the company's Health and Safety policy within the laboratory.
2. Ensure a safe working environment to meet site safety objectives.
1. Participate to the definition of strategy in terms of microbio lab & manufacturing facilities.
2. Drive major change projects for microbio lab.
1. Be a strategic partner in the implementation of production facilities from Development phase through the life cycle of the product, develop sampling plan and trend analysis.
2. Support the general objectives of the Microbio Lab in accordance with the company's objectives and formally assess the results with the adequate KPI (Key Performance Indicators) : safety, quality, lead time, social and environment.
3. Be recognized as the global UCB microbio expert to support the following activities for all UCB sites : method development, validation, release and stability testing for NCE and NBE projects from phase I trhough the life cycle of the product.
4. Be the key expert to train technicians to microbio methods ans support troubleshooting related to microbio for any UCB sites, Braine manufacturing and external partners.
5. Play a key role in the implementation of new lab technologies.
6. Drive CRO/CMO testing supporting release and stability testing.
7. Drive regulatory aspect linked to any microbio activities, ensure the interface between the microbio lab and Regulatory Affairs, and insure microbio testing being compliant to regulation requirement updates.
8. Develop and implement sampling plans for environnemental and utilities controls and quality systems to support this activity.
9. Ensure the continuous improvement of the laboratory
10. Ensure the lab infrastructure maintenance
1. Participte / do the update of procedures and instructions.
2. Ensure Follow-up or is responsable of corrective actions and preventive actions.
3. Participate to the preparation, the follow-up and the realization of the audits.
4. Ensure adequate personal development and training to improve competency level.
5. Ensure the follow-up of OOS and take actions to reduce the number of laboratories OOS.
6. Lead the CME "Environmental monitoring comitee".
1. Master degree and experience in a GMP microbio lab and people management.
2. Experience in microbio supporting Parenteral Facility.
3. Experience with FDA, European and Japanese investigators during on-site inspections, and experience interacting with Regulatory review staff on submission issues.
Ability to evaluate staffing and equipement needs versus project workload is essential. The areas of knowledge should include: microbiology, biology, parenteral expertise .
Must be able to manage the group.
Must have demonstrated ability to delegate tasks.
Requires the ability to validate decisions by utilizing strong analytical, troubleshouting and problem solving.
Must be able to manage multiple projects.
Excellent interpersonal, verbal, and written communication skills are required, with ability to balance multiple priorities.
Very high level of microbio troubleshooting and analytical skills are needed for support to Manufacturing and laboratory issues (including outsourcing lab).
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