Johnson & Johnson Services, Inc.
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Senior Scientist, located in Malvern, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The candidate for this position will be responsible for driving testing programs in raw materials, cell line characterization, unprocessed bulk testing and viral clearance studies to current industry standards and/or best practices. The candidate will provide technical review of test reports, test methods, resolve issues with external testing laboratories and lead investigations when required. Candidate may also manage direct reports. Responsibilities also include, but are not limited to the following:
Maintaining an awareness of current issues in adventitious virus testing for biopharmaceuticals, authoring technical documents, regulatory filings, supporting quality events and change controls, and contributing to technology transfer to collaboration partners
Responsible as a liaison with manufacturing sites quality control to provide technical oversight for clinical and commercial products
Work in a team environment as well as contributing individually to meet project timeline and objectives
Act as a mentor, advisor and technical subject matter expert to others in the company
A PhD in Virology or Biological Sciences or Biochemistry with at least 3 years of relevant post-graduate experience OR MS in Virology or Biological Sciences or Biochemistry and with at least 12 years of relevant experience OR a BS in Virology, Biological Sciences or Biochemistry and with at least 15 years of relevant experience is required
Experience working in a GMP environment is preferred
CMC regulatory experience is preferred
Knowledge of cell (e.g, CAR-T) and gene therapy (e.g., AAV, adenovirus) manufacturing and testing preferred
Experience managing people preferred
Expertise in virology, including familiarity with classical cell culture and nucleic acid testing methods are required; advanced viral detection systems (.e.g., high-throughput sequencing) is preferred
Experience maintaining written records of work in the form of (electronic) notebooks, technical reports and protocols is required
Data reporting, ability to present findings to management, and experience with team-based collaborations is a must
Occasional travel and weekend work may be required
Janssen Research & Development, LLC. (6084)
Johnson & Johnson Services, Inc.
Website : http://www.jnj.com
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. Johnson & Johnson was founded more than 120 years ago. Since then, we’ve brought the world new ideas and products that have transformed human health and well-being.