- 14 februari 2019
- vacaturenummer: 9063744
Yacht Life Sciences has a vacancy for a Scientist.
The Product Characterization group within the Analytical Development department is responsible for characterization of vaccine products from early to late clinical development phases. The group defines strategies for product characterization, coordinates characterization of virus seeds, drug substance, drug product, and reference materials, and plays a leading role in comparability studies and definition of critical quality attributes.
Job Description Scientist:
- Coordinate Product Characterization deliverables for one or more products under development at VPAD, for example, AdVAc© based vaccines
- Help define characterization strategies, write characterization plans and reports and coordinate the execution of characterization plans
- Lead the definition of product critical quality attributes, together with a cross functional team
- Write, together with the CMC team, comparability plans and reports
- Write or contribute to the applicable sections of regulatory dossiers
- Participate as a team member in cross functional project teams
- Participate in (internal and external) scientific meetings by giving advice or presenting characterization strategies and results
Specific Knowledge Scientist:
- Industry experience in development of biopharmaceutical or vaccine products
- Experience in regulatory filing at different clinical development phases up to and including Phase III/registration
- Experience with qualification and characterization of reference materials
- Experience with analytical comparability assessments
- Broad interest and scientific knowledge of physical chemistry and/or biology of proteins and/or viruses
- Understanding of quality systems such as GMP
- Understanding of regulatory requirements and guidelines on biopharmaceutical and vaccine development (e.g., FDA, EMA, ICH, WHO)
- Ideal candidate has a completed PhD in a relevant discipline such as analytical or physical chemistry, biochemistry or bio-pharmaceutical sciences and some post-PhD experience, but open to candidates completing their thesis as well
- Demonstrated written and oral communication skills (in English)
- Demonstrated ability to work both independently and as part of a team
- Multidisciplinary mindset; ability to communicate effectively across different scientific disciplines
- Excellent analytical and organizational skills
- Problem solving and results oriented; able to see and leverage different perspectives
- Pragmatic attitude
Secondment placement for 1 year, full-time. Extension is possible.
We will offer a competitive benefits package in line with the seniority of the position (3500-4000 euro gross per month).
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
A global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
Werken voor Yacht
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Uiteraard staat deze vacature open voor zowel mannen als vrouwen.
Deze vacature wordt via YACHT aangeboden. Het solliciteren en verdere contact verloopt via YACHT.