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 and Biotechnology organisation, based in Zuid-Holland Netherlands.The CompanyThis Multinational is specialized in biotechnology vaccines and biopharmaceutical technologies.

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.

• Empowering team members to act with speed, agility, and accountability
• Managing interface with other groups
• Delivering of DSD project deliverables
• Adherence to functional strategies of the line
• Timely escalation of conflicts affecting ability to meet project deliverables

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.

Other information32 hours discussable. NL not required, English is must. Most important skills: 1. pahrma process experience; 2. manufacturing process knowledge; 3. Project management skills; 4. communication/stakeholder 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 Asanka Boxma.




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