Technical Integrator Drug Substance Development

Bedrijfsnaam: -
Plaatsingsdatum: 24/09/2018
Standplaats: -


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 Company.

Role DescriptionThe individual leads a DSD project team and represents the team in the CMC project team. The Technical Integrator coordinates the departmental deliverables for 1-3 CMC projects in alignment with DSD line management as well as with other functional areas, like Analytical Development, Drug Product Development, Regulatory Affairs, Quality Assurance and Clinical Supply Chain.

Responsibilities• Represents the DSD department on the CMC project team, acting as a single point of contact for the CMC team leader
• Leads a functional sub-team containing DSD representatives and Subject Matter Experts (SME) and is responsible for the planning and execution of DSD project deliverables
• Develops the project strategy in consultation with the DSD 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 DSD
• Responsible for the generation of appropriate risk management scenarios
• Responsible for ensuring that adequate technical review of regulatory submissions is taking place by the appropriate SME and ensures consistency in content across submissions.

Requirements- Education: PhD (preferred) or MSc in relevant discipline, like pharmaceutical sciences, engineering, (bio)chemistry or other life sciences.
- Proven technical expertise in Drug Substance process development, 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.
- 5+ years relevant experience in pharmaceutical industry, preferably in a biopharmaceutical drug development environment.
- Other: Positive, pro-active and supportive attitude. Ability to lead and develop multidisciplinary teams of professionals in a matrix environment. Stakeholder management skills. Project management skills. Role model for cross-departmental collaboration.

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




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
5 - 10 jaar
Contactgegevens :