Assistant scientist
Gevonden in: beBee S NL - 2 weken geleden
Job Description Assistant Scientist
The Research & Development group of J&J Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases, and vaccines, cardiovascular and metabolism, and pulmonary hypertension.
The Drug Substance Development (DSD) department in Leiden focuses on advanced therapies, a novel class of medical products that uses cell and gene therapies to treat diseases which have the potential to cure diseases when no treatment is available. It's a very exciting field, as no established manufacturing platforms exists for these products, which means that new processes need to be developed to ensure high-quality and efficient production of GMP material.
The DSD process development and GMP manufacturing teams work as one team to enable fast delivery of the products for clinical trials, by together on developing the process, tech transferring it to the GMP pilot plant and then producing clinical trial material.
We are recruiting an assistant scientist to join our GMP manufacturing teams for the production of early-stage clinical trial material. We are seeking a highly motivated and engaged assistant scientist who will be highly involved in the manufacturing of the GMP material, while also supporting process development and tech transfer activities.
Key Responsibilities:
Participate in the development of upstream and downstream process steps by
- Carry-out experiments in the lab and pilot plant.
- Working with scientist in process development to learn more about the unit operations.
Bring the process from the lab to the pilot plant as part of a team by
- Writing and/or reviewing the GMP process documentation (SOPs, work instructions, batch records, etc.) required to perform the process in GMP.
- Doing water runs and training runs to ensure you're ready to perform production.
Perform GMP production by
- Ensuring production areas, materials and equipment are all ready for production activities.
- Performing engineering and GMP production runs according to protocols or SOPs, including accurately recording all process, equipment and material data.
- Coordinating with other departments (QA, logistics, QC, ...).
- Proactively identify and work on resolving problems that occur in production.
- Investigating deviations.
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