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 Company

Janssen Vaccines is committed to developing first-in-class or best-in-class vaccines for some of the world’s most life-threatening infectious diseases. We have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden, we have a workforce of 700 scientists and support staff, 45% of our employees has a nationality other than Dutch with over 20 nationalities represented. We partner with many of the world’s leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against, for example, Ebola and HIV.

Role Description

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.

Responsibilities

• 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

Requirements

• Education: PhD or equivalent experience in a relevant discipline such as analytical or physical chemistry, biochemistry or bio-pharmaceutical sciences
• 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)

Other information

This is a 1 year contract with the possibility of extension.

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