Johnson & Johnson Careers
Microbiology (Senior) Scientist
Requisition ID: 1905742461W
‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions
As part of Janssen R&D - Discovery, Product Development, and Supply (DPDS), the Microbiology Expert team has the following responsibilities:
- Providing global support for all microbiology-related aspects during clinical development (R&D) and life cycle management (commercial) of the entire Janssen product portfolio (Biologicals and Small Molecules)
- Coordinating microbial method development, validation/qualification and transfer activities with internal and external microbiology laboratories
- Microbial specification setting and control strategy
- Microbial risk assessments and investigation support
- Supporting regulatory inquiries in the field of microbiology
- Implementing innovative microbial technologies for established and new product platforms
In the Microbiology Expert Team (Beerse, Belgium) there is currently a full-time opening for a pharmaceutical microbiology expert (m/f) with a proven track record of project management related to microbial method validation, specification setting and control strategy in support of (bio)pharmaceutical product development in a global setting.
As subject matter expert (SME) in pharmaceutical microbiology you participate in multidisciplinary teams to support clinical drug product development (Biologicals and Small Molecules).
In this role, you:
- collaborate closely with internal and external microbiology laboratories globally to support GMP method validation/qualification activities (Bioburden, Sterility, LAL, RPT, AVA/Mycoplasma, etc.);
- ensure compliance with regulatory and internal requirements, GMP and safety regulations;
- apply current scientific knowledge to ensure high quality of the delivered results;
- author regulatory documents;
- perform microbiology impact/risk assessments for specific processes and products;
- provide on-demand expertise and solutions for investigations on R&D and commercial products;
- initiate and follow up collaboration with external partners with respect to innovative technologies;
- support customer and regulatory audits.
Education & experience
- You hold a Master and PhD degree in Bioscience Engineering, Biology, Biomedical Sciences or similar with a strong expertise in the field of microbiology, or you hold a Bachelor degree in combination with a proven track record in the specific area of pharmaceutical microbiology, in particular in the biopharmaceutical industry.
- The following experience and expertise are considered as important assets:
- Biological production process knowledge
- Experience with ATMP’s (such as cell therapy, gene therapy, etc.)
- Thorough GMP knowledge
- Ability to work independently yet also a good team player in an international setting
- Have high moral standards and assure scientific quality
- Good project management skills and able to handle multiple projects simultaneously
- Take on responsibility
- Results and performance driven
- Strong sense of urgency
- Efficient and flexible mindset
- Excellent communication skills (written and oral)
- Demonstrate capabilities in strategic thinking
- You have good knowledge of English (written and oral) The function can be taken up immediately and is a permanent position.
What’s in it for you…?
“Caring for the world, one person at a time…” As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
Janssen Pharmaceutica N.V. (7555)