Scientist PDMS-API-LM

Job description

Scientist PDMS API Large Molecules
Janssen Biologics Leiden


The department leads in the application of broad technical expertise, including new and innovative technologies, to the support of marketed products. Participates in high caliber multi-functional teams to drive solutions to commercial manufacturing problems and to drive process improvement, technology transfer, and process validation efforts. Performs high level research and development activities supporting high value commercial products. Performs technology transfer for new products and manufactures tox and phase 1/2a clinical material. Projects will often be high priority with high level interest and attention.

Responsibilities & Accountabilities:

This position will play a lead role in support of high value commercial products manufactured within the Leiden plant and plants in Ireland and the United States, helping to ensure uninterrupted supply of product to the market. This position will serve as a technical and scientific resource for large scale perfusion bioreactor operations and for large scale downstream purification processes. A solid theoretical foundation and practical experience in bioreactor process technology and antibody purification will be brought into practice for development and introduction of new tox and phase1/2a clinical products. This position may take on responsibility for specific products and as such may be responsible to lead site product teams or act as scientific or technical lead during technology transfers of new products.

Desired profile

Qualifications :

Qualifications, Education, Skills & Experience:

·  Typically Ph.D degree or equivalent experience in Biotechnology, Bioprocess Engineering, Biochemistry, Biochemical engineering or related field
·  0-3 years post-doctoral experience or at least 3 years of experience at Sr. Associate Scientist level.
·  Strong technical orientation and in depth understanding of API large molecule manufacturing
·  Personal characteristics: Analytical and innovative thinker, adaptable and flexible and good problem solving skills. Highly results driven, with focus on customer satisfaction and on-time completion of projects.
·  Excellent interpersonal and collaborative skills, both oral and written, fluent in both Dutch and English, to support working in an international environment with frequent contact in the United States, Ireland and Belgium as well as in Leiden.
·  Familiarity with Process Excellence and Six Sigma techniques is a plus.
·  Experience with statistical software packages (e.g. Minitab) and Multivariate analysis is a plus
·  Experience with Process validation, Process improvements and Commercial manufacturing support.