Director, Viral Vector Analytics
Malvern, PA, USA | Johnson & Johnson
Job Description:54 people have viewed this job
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.
- 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.
- 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
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