Scientist
7 maanden geleden
The Research & Development department 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 will focus on advanced therapies, a new class of medical products that use genes and cells to treat diseases. These novel medicines have the potential to cure diseases when no treatment is available. No established manufacturing platforms are available for these products, which means that new processes need to be developed to ensure high-quality and efficient production of GMP material. The processes will be developed in close collaboration with the process development teams in the broader DPDS organization. The DSD department in Leiden also has a GMP pilot plant for in house production. The process development and the GMP manufacturing teams work as one team to enable fast delivery of the products for clinical trials.
We are recruiting a scientist process development for our drug substance development department that wants to help build the new organization. We are seeking a highly motivated and independent scientist that will lead process development activities, tech transfer activities, author technical reports and regulatory filings and support the manufacturing of the GMP material.
**Key Responsibilities**:
- Proactively develop upstream and downstream process steps, bring the process to the pilot plant and support production.
- Design, carry-out, supervise and report experiments in the lab and pilot plant
- Select process equipment and raw materials based on process requirements.
- Create real-time learnings based on data from the lab
- Identify and implement improvements in existing production processes and work processes with a continuous improvement mindset.
- Implement digital tools, such as PAT and process modelling in own projects.
- Present work and ideas in group meetings and participate in internal and external seminars
- Manage research projects and ensure delivery of business results.
- Ensure the availability for lab capacity
- Troubleshooting of issues in the development and production processes, in collaboration with other departments
- Stay up to date of scientific literature and patents.
- Train and coach associate and assistant scientists, team members and trainees
**Qualifications**:
**Qualifications**
**Education**:
BSc with 7-15 years or MSc with 5-8 years or PhD with 0-3 years of Pharma/biotech industry/Postdoc experience.
**Experience and Skills**:
- Experience in bioprocess development of multiple process unit operations, preferably at different scales
- Troubleshooting skills and good understanding of GMP manufacturing
- Strong knowledge of experimental design, execution, and analysis
- Knowledge of analytical assays supporting process development
- The ability to “ask the right questions” in a discipline outside of your core expertise.
- The ability to rapidly assimilate new technologies and / or knowledge.
- Strong connect and collaboration skills.
- Project management skills, such as FPX or rapid learning cycles
- Ability to define and articulate risks and manage mitigations in early process development.
**Other**:
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