GMP Specialist

Job Title: GMP Specialist

About the Role:
Johnson & Johnson is recruiting a GMP Specialist to join our Operational Readiness team in Johnson & Johnson.

About the Team:
As a global market leader, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

About the Role:
We are seeking a skilled GMP Specialist to support our new facility, which will manufacture the Lenti Viral Vector for our customers. This process involves different steps from cell expansion, virus production, and clarification to automated filling and labeling, performed under strict GMP and BSL2 conditions. The successful candidate will work closely with the project team to prepare the plant for operations, support technology transfer from R&D, develop procedures and training, and produce test and qualification batches.

Responsibilities:
- Develop and maintain GMP-related documentation and procedures
- Collaborate with the project team to ensure adherence to GMP standards
- Support technology transfer from R&D to manufacturing
- Develop site performance management tools and facilitate investigations
- Ensure compliance with regulatory requirements and industry standards

Requirements:
- Bachelor's degree in biotechnology, biochemistry, biomedicine, or process technology
- 2-8 years' experience in biotechnology or biopharmaceutical industry environment
- Good communication skills in English and Dutch
- Experience in Quality Systems, specifically Change Control
- Working knowledge of cGMP standards
- Preferred knowledge of sterile processing, drug product filling, and Annex 1 regulations

About Johnson & Johnson:
We are a global leader in healthcare innovation, with a commitment to being the world's healthiest workforce. We offer a dynamic and inspiring working environment, opportunities for career growth and continuous personal and professional development, a strong global network of talent and expertise, and a competitive benefits package.

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