CMC Leader
| Werkgever | CLS Services |
|---|---|
| Plaats | Leiden |
| Provincie | Zuid-Holland |
| Land | Nederland |
| Dienstverband | Voltijd (> 36 uur) |
| Contract | Vast |
| Plaatsingsdatum | maandag 12 juli 2010 |
Functieomschrijving
CLS Services is a leading professional recruitment agency, specialised in the recruitment of people with a background in chemistry or life sciences. For our client, Crucell, we are searching for a CMC Leader.
As CMC leader you are responsible for the:
-Management of the interface between the Program Directors and PD in order to translate program needs into PD work packages;
-Preparation of a Program Development Plan for PD after transfer of a program through the program directors to PD;
-Elaboration of an annual Process Development roadmap which ensures an optimal balance between capacity and resources availability and the program needs;
-Point of Contact (POC) of PD to all interfaces regarding program related issue;
-Assure delivery all the required information through PD for a successful and timely registration with all concerned authorities (EMEA/FDA);
You propose and manage the necessary budget based on the roadmap of Process Development for the individual programs. Further you manage employees in PD through the programs in such a way that they are motivated to contribute in reaching the PD objectives.
Within this position you have strong interaction with the QA and RA group to align the deliverables (documentation) of the programs with the guidelines.
As CMC leader you are responsible for the:
-Management of the interface between the Program Directors and PD in order to translate program needs into PD work packages;
-Preparation of a Program Development Plan for PD after transfer of a program through the program directors to PD;
-Elaboration of an annual Process Development roadmap which ensures an optimal balance between capacity and resources availability and the program needs;
-Point of Contact (POC) of PD to all interfaces regarding program related issue;
-Assure delivery all the required information through PD for a successful and timely registration with all concerned authorities (EMEA/FDA);
You propose and manage the necessary budget based on the roadmap of Process Development for the individual programs. Further you manage employees in PD through the programs in such a way that they are motivated to contribute in reaching the PD objectives.
Within this position you have strong interaction with the QA and RA group to align the deliverables (documentation) of the programs with the guidelines.
Profiel
| Opleiding | Gepromoveerd |
|---|---|
| Ervaring | Ervaren (3 - 8 jaar) |
|
For this position we are looking for a candidate with a background in cell biology/biotechnology/bioprocess engineering or significant project management experience. You need 5 years experience in a biotech GMP manufacturing plant. Further you must have a minimum of at least 3 years experience of leading projects and people in a multi national environment.
|
Aanvullende informatie
Crucell is a fully integrated biopharmaceutical company. As the largest independent vaccine company in the world, they focus on developing and marketing vaccines and antibodies against a range of infectious diseases. Crucell currently has a product portfolio of vaccines against influenza, hepatitis A, hepatitis B and typhoid fever.
Several Crucell products are based on their unique PER.C6® production technology. Crucell licenses this and other cutting edge technologies to the biopharmaceutical industry. Important partners and licensees are DSM Biologics, Novartis, sanofi aventis, MedImmune, GSK, CSL, Merck and Wyeth.
Headquartered in Leiden, The Netherlands, Crucell currently employs about 1100 people and has subsidiaries in Switzerland, Spain, Sweden, Italy, Korea and the United States. Crucell N.V. is listed on Euronext and NASDAQ (CRXL) and the SWX Swiss Exchange (CRX). At Crucell, they’re bringing innovation to global health.
Within Crucell talented, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.
Several Crucell products are based on their unique PER.C6® production technology. Crucell licenses this and other cutting edge technologies to the biopharmaceutical industry. Important partners and licensees are DSM Biologics, Novartis, sanofi aventis, MedImmune, GSK, CSL, Merck and Wyeth.
Headquartered in Leiden, The Netherlands, Crucell currently employs about 1100 people and has subsidiaries in Switzerland, Spain, Sweden, Italy, Korea and the United States. Crucell N.V. is listed on Euronext and NASDAQ (CRXL) and the SWX Swiss Exchange (CRX). At Crucell, they’re bringing innovation to global health.
Within Crucell talented, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.
Contact
Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (Please use button *Direct solliciteren*)(Vacancy number A1000088)
For more information please contact Jan Paul Favier at +31 (0)317 47 96 65
Bedrijfsprofiel
As a dynamic company CLS Services is dedicated to recruiting top level professionals in chemistry and life sciences. Clients appreciate our professionalism, flexibility and ability to come up with tailor-made solutions for any specialist function. Founders and directors Jan Paul Favier and René Kemps both have relevant technical backgrounds and extensive experience in high-level recruitment in the CLS Services sector. In short time we have built up an impressive track record and now serve multinationals as well as smaller and more specialized biotech, chemical, pharmaceutical and food companies.
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