Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director/Principal Scientist, Virology for our site in Malvern, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The candidate for this position will provide scientific leadership in the area of viral safety and be responsible for driving virology 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 external partners protocols, reports, methods, coordinate with and resolve issues with external laboratories and lead activities when required. Candidate may also manage direct reports. Responsibilities also include maintaining an awareness of current issues in viral safety 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. Knowledge of cell and gene therapy manufacturing and testing preferred. The candidate is expected to work in a team environment as well as contributing individually to meet project timeline and objectives.
The position requires extensive expertise in virology, including familiarity with classical cell culture, nucleic acid testing methods and advanced viral detection systems. Requires substantial communication skills including experience with regulatory agencies, technical writing ability to ensure studies are performed properly and data presented in regulatory documents are understandable to the regulatory community. The candidate will act as a mentor, advisor, and technical subject matter expert to others in the company.
Qualifications
- A PhD in Virology, Microbiology, Biological Sciences or Biochemistry with at least 6 years of relevant business experience OR at least 3 years of experience performing progressively advanced duties at the Senior Scientist level, or equivalent training/ experience is required with a minimum of a bachelor's degree.
- Knowledge and hands-on experience in cell culture, virology, and nucleic acid methods are required.
- Knowledge of cell therapy and gene therapy manufacturing, and testing preferred.
- Experience working in a GMP environment is preferred.
- CMC regulatory experience is preferred.
- Experience managing people preferred.
- The candidate must be highly organized and capable of managing/pursuing multiple projects independently.
- Good written and verbal communication skills are required.
- 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.
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.
Primary Location
United States-Pennsylvania-Malvern-200 Great Valley Parkway
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
W