Director, Viral Vector Analytics

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Viral Vector Analytics within in our Cell and Gene Therapy Analytical Development team located 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 www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. The Biotherapeutics Development and Supply – CGTV Analytical Development (BTDS – CGTV AD) group is seeking an energetic, highly motivated Director to lead an analytical team in method development and viral vector characterization. The individual will lead an organization of >20 members, who are involved in developing infectivity, process impurity, characterization methods for lentivirus vectors, gene therapies, oncolytic viruses, and bacteriophage development of cell therapies from NME declaration through commercial licensure. This is an emerging class of medicines that includes viral vectors used in cell therapies, gene therapies, oncolytic viruses and similar modality types such as bacteriophages. Lead a team of 20-50 scientists (internal and contractors) who are focused on method development and product characterization for gene therapies, oncolytic viruses, bacteriophage, and RNA therapeutics. Lead will be responsible for the shaping the technical and regulatory strategies for measuring the appropriate critical quality attributes within this growing field. Team will be responsible for the following: Develop/validate/transfer methods to measure viral infectivity, process impurities (full, empties, overpacks, intactness of transgene), and in vitro potency using commercial or genetically modified cell lines. Develop characterization strategies and implements plans to understand viral capsid components for both enveloped and nonenveloped viruses. Develop sequencing technologies to characterize the viral transgene. Support the in vivo potency assay methods through technical know-how. Establish a virus characterization tool box that includes but is not limited to molecular assays for content, intactness, impurity measurements (TaqMan, ddPCR, dPCR), infectivity methods with various detections (plaque, flow, mRNA), microscopy to measure viral binding and kinetics of infectivity, to support process/product development and routine characterization testing. Engage and/or lead technical investigation strategy in support of product investigations with respect to clinical outcomes or adverse events driving to root cause. Lead technical forums both internal and external to the company to share knowledge and approaches related to gene therapies, viral vectors, oncolytic viruses, bacteriophage, and RNA products. Develop innovative approaches to challenging solutions both technical and shaping health authority strategies. Identify/collaborate with partners in academia or industry to execute on innovation ideas or characterization approaches Effectively communicate scientific data and results across technical teams, project teams, and to the health authority as needed. Qualifications Ph.D. in virology, cell biology, immunology, biological science, or related discipline with at least 12 years of experience OR a M.S. in virology, cell biology, immunology, biological science, or related discipline with at least 15 years of experience is required Pharmaceutical industry experience is required Proven track record in leading a scientific team with direct and/or indirect people management experience required In-depth experience in viral vector and/or gene therapy development including analytical strategies and experience in authoring and reviewing relevant portions of IND and BLA required. In-depth expertise in developing/validating methods for routine testing and characterization required Experience establishing a virus characterization tool box that includes molecular, biophysical and infectivity assays is preferred Excellent oral and written communication skills required Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment with a growing portfolio required Ability to work collaboratively in a complex, matrix/functional environment required Strong understanding of analytical method development/qualification/validation and GMPs required Demonstrated experience and strength in preparation of global regulatory filings and preparing responses to questions preferred Travel: Up to 10% as per business needs At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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. 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 2206039372W