Project Manager (Analytical Development)
That's XPE. For one of our clients we are looking for: Project Manager (Analytical Development) Organisation description:
XPE Pharma & Science offers a unique combination of providing high qualified Scientific, Technical, Commercial and/or Medical expertise through staffing, consultancy, Project management or Project delivery services.
We have more than 250 XPErts helping out our clients in different phases of the development process of a drug/medical device or product.
As a full service organization XPE Pharma & Science offers those specialized HR & project services to Pharmaceutical, Biotech, Medical devices, Agro-food Industries and the Healthcare & CRO environment.Job description:
This position require a strong understanding of analytical disciplines related to CMC activities.
In close collaboration with the Analytical Product Owner (APO) of a designated commercial product (monoclonal antibody), provide support for the writing of stability report, specification setting justification report and manufacturing trending reports. These reports will be uses to support the world wide regulatory requirements.
This is a complex matrix environment with a lot of different stakeholders. The project manager must be able to create quickly a network (dispersed over different sites (Bulle, Braine, US)) and different departments (mainly QC, QA, RA). This mission does not include any laboratory work.
Redaction of technical protocol and report & responsibilities may vary depending on project team need.
The project manager will report to the APO who will take the commercial lead. The APO will turn to the project manager for operational issues.Profile:
- Master's degree required in analytical chemistry (applied to biological products / NBE), biochemistry, biology
- Analytical expert with experience (2 years+) in the pharmaceutical analysis of New Biological Entities and more specifically monoclonal antibodies
- Strong understanding of all analytical disciplines related to CMC for late stage development and commercial products (analytical development, stability testing and quality control of drug substance, drug product)
- Exp in Regulatory Affairs and Quality applied to analytics
- Experience in GMP is a must
- Fluent in English and French
- Strong sense of accountability and responsibility, with the ability to manage priorities
- Demonstrated experience in the writing of GMP documentation
- Ability to manage paralell activities, within different projects
- Ability to manage interfaces with laboratory operations
- Key technical background: chromatography (LC); electrophoresis, detection techniques (UV/Vis, MS); LC-MS, , USP, EP, and JP tests Large molecule experience is a plus
- Ability to identify pro-actively (anticipate) and address potential problems or areas for improvement and act on them in a problem-solving manner
- Business driven with a view to overall strategy
- High level of analytical troubleshooting skills to support manufacturing and laboratory investigations with our laboratories
What do we offer? Well for this position you will start as a Consultant at XPE Pharma & Science. As a consultant you will get an interesting salary package (contract of unlimited term) and extra legal advantages!
If you are still interested, don't hesitate to apply…We have 2 working days to present your application with our client.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713