Project Manager Pharmaceuticals (Generic)
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Netherlands.
The client is operating globally and specialised in producing pharmaceutical compounds under high quality standards. Their niche is strongly oriented towards novel compound formation and aims for scaling up their business.
ROLE DESCRIPTION
For this role it is necessary to perform in optimal cooperation with Clinical Research Organisations (CRO's), Contract Manufacturing Organisations (CMO’s), regulative affairs consultants and other professionals experienced in development, manufacturing and marketing/sales of the clients products.
You will be central point between these parties and work with closely with the clients' other global departments.
You will be constantly in touch with the responsible working teams to work fully on the formulation development responsibilities of the project.
RESPONSIBILITIES
- Leading all the pharmaceutical technological operations in order to successfully meet the requirements of transition of a product in to the commercial scale
- Revising and approving the technical documentation provided by CRO's, Contract Manufacturing Organisations and regulative consultants
- Manage and control the different stages of the studies
- Support and underwrite the compilation of the documentation of the dossier
- Being able to decide on requesting external knowledge needed for the development stages
- Cooperation with Regulatory Affairs in order to apply for submission strategy
- Share technical knowledge and support concerning IP and legal cases
REQUIREMENTS
-More than 5 years of experience in manufacturing and up scaling of (generic) pharmaceutical products
-Known to the process of taking products from scratch to registration
-Likewise experienced with generic products
-Familiar to cooperating with other third parties
-Well-trained in professional management skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Hanneke de Koning.
