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Attendeer FMF hierop
Sr. Project Manager CMC (1,0 FTE)
Temporary position as a project manager within CMC projects for at least 1 year in the pharmaceutical industry
Het bedrijf / The company
Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is in Leiden, but has tight lines around the world. For the Project and Product Management department they are looking for support. Therefore, they would like to meet an experienced Sr. Project Manager CMC with heavy project management skills on a global level.
De functie / The role
As a Senior Project Manager CMC you will be responsible for the coordination and management of Chemistry, Manufacturing and Control (CMC) activities of global and all regional products, during drug development and the complete product life cycle. Therefore you will be assigned to commercial products, that are currently in the last phase of Life cycle management and have been transferred to a foreign country. It is therefore a must that you communicate with Supply Chain Management to ascertain there are no delays on the logistics and distribution of the drug products. The transfer will go to a Contract Manufacturing Organisation (CMO) in Russia. Therefore you need a clear overview of the project to manage it on time and in the budget. You will work in a matrix structure and you will motivate people to collaborate keeping up with the timelines for the projects. You will represent the Technology Division in alliance and partner programs for the prospective of CMC management. On the team you will work together with 13 other specialists, regarding CMC Management and report to the head CMC Manager. You will also align Senior Management and inform the key stakeholders in and outside the organisation.
Het profiel / Your profile
o Master degree in pharmaceuticals or life science
o at least 5 years of experience in the pharmaceutical industry where 3 years in a similar position in CMC Project Management
o demonstrated leadership skills in a matrix organization with a successful track record
o understanding of GMP and ICH guidelines and quality requirements
o demonstrated excellence in communication, negotiation/influencing, and social skills with a good sense of diplomacy both in a scientific and industrial environment, both relating to peers and higher management
o understanding of the implementation and impact of regulatory requirements and guidance / internal SOPs / PM concepts (experience with co-licensing development is an advantage)
o understanding of the economical contribution of CMC to the overall business processes (e.g. cost of goods, impact of CMC development and manufacturing)
o communication and project management skills to manage international and multidisciplinary teams during CMC development, product launch and maintenance
o demonstrating analysis priority setting of various issues, analyse skills and able to manage at high level
o good communication and reporting skills in English, both written and oral
Het aanbod / The offer
o diverse job within a pharmaceutical company
o interesting because you work on tech transfer projects
o temporary contract with the possibility to extend
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-097-FMF, to Sandra van Putten: email@example.com. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.