Stability and Critical Material Scientist. - Braine l'Alleud, Belgium
Posted on Sep 30, 2020 by ABW Recruitment
My Client a Leading Pharmaceutical Company based in Belgium requires a Stability and Critical Material Scientist
- NCE and NBE
- Critical materials and supportive stability from phase III until the end of life cycle of products
- Provide and develop NBE and NCE stability and Critical Material (CM) knowledge and expertise on UCB product, regulation and processes
- Ensure and participate, where relevant, to an efficient interface with QC and development laboratories, Corporate analytical services, Manufacturing and Supply chains Department, Global Regulatory affairs.
Describe the main accountabilities for this role including significant tasks, responsibilities and projects
- Provide and develop NBE and NCE stability and CM knowledge and expertise on my clients product, regulation and processes
- Participate to the interface, where relevant with QC and development laboratories, Corporate analytical services, manufacturing and supply chains Department, Global Regulatory affairs, CLO,
- Participate to the management of regulatory aspect linked to the stability and CM activities
- Contribute to the operationnall design of stability study
- Follow up of stability program in scope
- Review and approval of protocol
- Review and approval of report
- The position can act as back-up for his/her direct colleagues or for his/her manager according to the Stability and Critical material Manager instructions and after appropriate training
- Manage and optimize the availability and central stock for analytical supplies for my clients activities and Central stock of Reference Standards
- Participate to the development and the implementation of a Corporate repository for analytical supplies
- Act as key user/expert LIMS stab, E-study, Disco and LIMS std and reagents
- Ensure product and system training and sharing of knowledge with less/no experienced member of the team
- Ensure supervision of climatic chambers, sample storage, sample flow
- Mentoring of stability and critical material partner .Contribute to the preparation, the follow-up and realization of the audits
- Manage or participate to improvements projects
- Update procedures and instructions on request
- Ensure follow up of deviations and appropriate root cause analysis
- Ensure follow up of preventives and correctives actions
- Ensure adequate training to maintain and improve competency level.
- Participate to implementation of safe working environment to meet site safety objectives.
- Participate to the establishment of investment and OPEX budgets
- Master + 3 years in pharmaceutical industry
- Strong NCE and NBE Analytical expertise is a must.
- Experience in both the R&D and commercial areas of the pharmaceutical industry required.
- Must have experience in a GMP regulated laboratory
- Experience with FDA, European and Japanese investigators during on-site inspections, and experience interacting with Regulatory review staff on submission issues.
- Areas of expertise should include: NBE & NCE analytical knowledge, critical materials and stability regulation and processes.
- Requires the ability to validate decisions by utilizing strong analytical, troubleshouting and problem solving.
- Must be able to manage multiple projects.
- Must be team oriented, in a transversal mode.
- Scientific Problem solving.
- High level of Stability and CM troubleshooting/trend analysis needed for support to Manufacturing (including outsourcing lab).