Project Manager Analytical Development
SIRE Life Sciences®
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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 and Biotechnology organisation, based in Zuid-Holland Netherlands.
The CompanyThey are a Biopharmaceutical company that specializes in the development of vaccines to cure infectious diseases worldwide.
Role DescriptionYou will be responsible for the technical representation of the line organization in CMC project teams. Coordinating project deliverables in close collaboration with the CMC Team Lead and functional line management. Furthermore you will support project objectives and grow departmental functional expertise to maximize the generation and use of knowledge.
Responsibilities- Represent the functional area (Analytical Development) on the CMC team and act as a single point of contact
- Lead a functional sub-team containing other functional reps and SME
- Project related functional area deliverables during all CMC stage gate phases
- Functional budget management and operational planning
- Developing the project functional strategy and the plan in alignment with CMC team/TPP
- Indicates gaps and or deficiencies in departmental functional strategies and or infrastructure
- Stimulates collaboration between the functions and ensures that the internal and external customer requirements are well understood by their teams to ensure development
- Maintain oversight and control over activities at CMO
- Responsible for risk management scenarios, continuous optimization, coordinating of spec setting process for functional area and technical content of regulatory submission
Requirements- MSc degree or PhD in Chemistry, Pharmacy or related area
- Technical expertise in Analytical Development, drug development/commercialization process, GMP or regulatory process experience is required
- 8+ years of experience in the Pharmaceutical industry (preferably in a Biopharmaceutical drug development environment)
- Team development and project management skills
- Fluent in English (oral and written), Dutch is a plus
Other informationThis is a fulltime job, 32 hours is discussable. Must be able to be on-site at least 3 days a week.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.