We lead in applying technical expertise and innovative technologies to support the manufacturing of both commercial and clinical products. We are looking for a standout colleague to drive improvements and builds relationships across departments in an international environment. In our pilot plant, we produce clinical products ranging from tox to phase 1/2a material. In our lab, we develop processes in small scale bioreactors and downstream processing. The entire department works together to bring new products to the patient and to support commercial products. We lead and contribute to highly visible projects in a dynamic and international Research and Development environment!
Responsibilities & Accountabilities:
As a Scientist for clinical production you are responsible for the Technology Transfer of the process from vial thaw until final fill of the Drug Substance. Writing Batch records, Technology Transfer documents and coordination of all the logistics with respect to materials and equipment for the clinical production. In this role, you interconnect between the dynamic environment of Research and Development and the reality of GMP manufacturing.
For commercial manufacturing support, you will be involved in major process improvements in collaboration with the Janssen Supply Chain. This work involves process development at a small scale, being part of a team for large scale engineering batches, PPQ batches, and regulatory submission writing. In addition, Scientists apply the latest Technological Innovations into our daily work. One of the major innovations currently explored is data management and statistical analysis applied to bioprocessing.
Qualifications, Education, Skills & Experience:
· Ph. D. degree or post-doctorate degree with at least 3 years of experience in Biotechnology, Bioprocess Engineering, Biochemistry, Biochemical engineering
· Technical knowledge on bioreactor process technology and downstream purification of large molecules (protein/Antibodies/duo bodies) for R&D purposes (GLP toxicology & GMP clinical)
· Familiarity with Process Excellence and Six Sigma techniques.
· Experience with data management techniques, statistical software packages (e.g. Minitab), Multivariate analysis and PAT
· Experience with process validation, process improvements, and manufacturing support.
· Personal characteristics: highly oriented towards results, with a focus on customer happiness and timely completion of projects.
· Excellent interpersonal and collaborative skills, proficient in both Dutch and English, to support working with frequent contact in the United States, Ireland, Belgium, and Leiden.
personal skills: start directly, ownership, not a lot of guidance, feel comfortable, being pro-active
Job combination: documentation, Word Excel, Teams & meetings, equipment but also speak to Operators
80% laptop work, 20% on the floor manage materials/people - 1/2 days per week onsite in Leiden
option to extend after one year depending on performance
large molecules background, chromatography, protein, biopharmaceutical
English must have, Dutch nice to have
pref. PhD, but also Msc with 5 years relevant work experience okay
currently 10 NPI projects, this person dedicated to one project
plus: experience with antibodies, large proteins
Product: Oncology, Autoimmune diseases - product for first clinical trials - impact on society / novel therapies
1 or 2 interviews taking place mid March 2021