J&J Innovative Medicine is recruiting for Lead technician / Associate Scientist, located in Leiden.
Job Description Lead technician
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, cardiovascular and pulmonary hypertension.
The Advanced Therapies Pilot Plant (ATP) in Leiden produces clinical trial material for advanced therapies, a novel class of medical products that uses cell and gene therapies to treat diseases and have the potential to cure diseases when no treatment is available. It’s a very exciting field, as no established manufacturing platforms exist for these products, which means that new processes need to be developed to ensure efficient production of high-quality GMP material!
The ATP is a very active pilot plant, with 3 full GMP productions streets for drug substance, and a 4th production street for drug product production being created, making it a true end-to-end pilot plant! The ATP teams also work in close collaboration with the process development teams to enable fast delivery of the products for clinical trials.
We are recruiting a lead technician to join our GMP manufacturing teams. We are seeking a highly motivated and independent person who will be highly involved in establishing operations for the new fill line, tech transfer activities, and the manufacturing of the GMP material.
Key Responsibilities:

Tech transfer the process from the lab to the pilot plant together with your team by

• Plan, distribute and follow-up on the work required with your team.
• Write and review the GMP process documentation (SOPs, work instructions, batch records, etc.) required to perform the process in GMP.
• Plan and lead water runs and training runs to ensure your team is ready to perform production, and well skilled in aseptic processing
• Give input in the selection of process equipment and raw materials based on process requirements.

Perform GMP production by

• Ensures production areas, materials and equipment are all ready for production activities.
• Leading your team in the execution of engineering and GMP production runs, as well as aseptic process simulations.
• Coordinate with other departments (QA, logistics, QC, …).
• Proactively identify and work on resolving problems that occur in production.
• Investigate deviations.
• Identify improvements for future runs.

QUALIFICATIONS

Education:
BSc or equivalent with 3-5 years or MSc or equivalent with 2-3 years of Pharma/biotech industry experience.

Experience and Skills:

• Experience with sterile manufacturing and working on a drug product filling line
• Experience in bioprocess development or GMP production
• Troubleshooting skills and good understanding of GMP manufacturing
• Strong connect and teamwork skills.
• Project management skills
• Strong communication skills in English

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

Please refer the Job description for details