Project Manager (Analytical Development)

6 jours restants

Région
Braine-l'Alleud
Publication
mercredi 31 mai 2017
Date limite
vendredi 30 juin 2017
Réf
6D64EXPE-BE
Contact
Julie Begine
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
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, Agri-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.

Your main role is the redaction of technical protocol and report (including data consolidation and analysis (in collaboration with a statistical team)).

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:

You have a Master's degree required in analytical chemistry (applied to biological products / NBE), biochemistry, biology, a experience as analytical expert (2 years+) in the pharmaceutical analysis of New Biological Entities and more specifically monoclonal antibodies and a 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).

You have a good knowledge of GMP , you speak Fluent in English (Mandatory) and French and a technical background: chromatography (LC); electrophoresis, detection techniques (UV/Vis, MS); LC-MS, , USP, EP, and JP tests. (Large molecule experience is a plus).

You are able to identify pro-actively (anticipate) and address potential problems or areas for improvement and act on them in a problem-solving manner and a high level of analytical troubleshooting skills to support manufacturing and laboratory investigations with our laboratories.

Offer:

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 is a part of the Adecco group, one of the top 5 companies for 'Best Place To Work'.



Licenses
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