Technical Integrator

Bedrijfsnaam: -
Plaatsingsdatum: 01/05/2019
Standplaats: -

Functieomschrijving

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.The CompanyJanssen Vaccines is committed to developing first-in-class or best-in-class vaccines for some of the world’s most life-threatening infectious diseases. We have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden, we have a workforce of 700 scientists and support staff, 45% of our employees has a nationality other than Dutch with over 20 nationalities represented. We partner with many of the world’s leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against, for example, Ebola and HIV.

In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen Vaccines.

Role DescriptionThe individual leads the DPD project team and represents the team in the CMC project team. The Technical Integrator coordinates the departmental deliverables for 2-3 CMC projects in alignment with DPD line management as well as with other functional areas, like Analytical Development, Drug Substance Development, Regulatory Affairs, Quality Assurance and Clinical Supply Chain.

Responsibilities- Represents the DPD department on the CMC project team, acting as a single point of contact for the CMC team leader
- Leads a functional sub-team containing DPD representatives and Subject Matter Experts (SME) and is responsible for the planning and execution of DPD project deliverables
- Develops the project strategy in consultation with the DPD department and CMC team in line with project targets, while ensuring alignment across the organization
- Drives partnership and collaboration between the functions and ensures that the customer (internal & external) requirements are well understood by their teams and are used as main drivers for development
- Responsible for budget preparation and alignment within DPD
- Responsible for the generation of appropriate risk management scenarios
- Responsible for ensuring that adequate technical review of regulatory submissions has taken place by the appropriate SME and ensures consistency in content across submissions.

Requirements- Education: MSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering.
- Proven technical expertise in at least one of the functional areas (DS, DP and Analytics), broad knowledge of the pharmaceutical industry and knowledge of functions involved in drug development/commercialization process, GMP and regulatory process experience is required.
- Experience with vaccines is preferred.
- A minimum of 5 years pharmaceutical industry experience, preferably in a biopharmaceutical drug development environment

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.

 

Aanbod/arbeidsvoorwaarden
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Samenvatting

Plaatsingsdatum :
01/05/2019
Referentienummer :
98701
Standplaats :
-
Adres :
-
Postcode :
9723 HK
Opleidingsniveau :
HBO
Uren :
Nader te bepalen
Dienstverband :
Vast
Werkervaring :
< 1 jaar (starter)
Contactgegevens :
bekijk