CMC Manager

7 jours restants

Région
Liège
Publication
jeudi 27 septembre 2018
Date limite
samedi 27 octobre 2018
Réf
83886XPE-BE
Contact
Julie Mertens
Fonction
Autre
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: CMC Manager Organisation description:

Are you looking for the next step in your career? Then keep on reading! As Head of CMC, you are responsible for all CMC-related technical operations activities, including overall management of process and product development, selection and oversight of the pharmaceutical supply chain, technology transfer, manufacturing and supply of clinical trial material. You ensure the Quality and RA compliance of CMC-related activities with the corporate policies. Our client is a clinical stage biopharmaceutical company focused on the development and future commercialization of a range of breakthrough immunotherapy products for the treatment of allergies, based on its technology platform.

Job description:

You report directly to the CEO and are part of the executive management team. In this dream job, here are your main responsibilities: You lead the overall management of product and process development. You manage all drug substance and drug product activities from technology transfer to clinical supplies for clinical studies. You identify, select and manage CMOs for process optimization, cGMP manufacture, supply, testing, release and distribution of Drug Substance (API) and Drug Product (DP). You manage the non-GMP productions and associated analytical development activities. You deliver robust, scalable and cost-effective manufacturing routes. You implement appropriate analytical methods and protocols in coordination with QA. You ensure the compliance of all CMO with relevant regulatory standards. You define and execute plans for API and DP validation and registration, in coordination with QA and RA

Profile:

Is this your new job? You have ideally a PhD in Life Science with at least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment. You have relevant expertise in lab techniques focused on protein expression, isolation and analysis. You have a strong experience in managing CMOs for the manufacture of cGMP APIs and DP. You are experienced in cGMP manufacturing and IND, CTA and NDA regulatory filings. You have thorough knowledge of relevant FDA and EMEA regulations. You are a born people manager. You have some experience with implementing technical, strategic and operational plans. You have excellent communication and organizational skills. You are able to identify and resolve critical issues. You have a good knowledge of French and English.

Offer:

What can you expect? A full time permanent contract, diversified tasks and responsibilities combined with interesting projects A professional, dynamic and stimulating work environment, with training and development opportunities A competitive salary package including benefits, adapted to your experience



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

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