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Scientific Director, Immunogenicity Assay Development (Protein Therapeutics & siRNAs)

Auris Health

Auris Health

United States
Posted on Friday, July 7, 2023
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Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientific Director, Immunogenicity Assay Development (Protein Therapeutics & siRNAs) located in Spring House, 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 successful candidate will join the Immunogenicity and Molecular Biology team within Bioanalytical Discovery and Development Sciences (BDDS) organization. The Immunogenicity and Molecular Biology team develops and validates assays to assess immunogenicity against biotherapeutics, cell/gene therapies, siRNAs, and other modalities as well as molecular biology assays to characterize cellular kinetics and biodistribution of cell/gene therapies. The Scientific Director will develop, validate and implement assays for characterizing anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) against biotherapeutics, ADCs, peptides, siRNAs, and other modalities as needed, to support nonclinical and clinical studies during drug development.

Qualifications

Education:

  • PhD in Immunology, Virology or related biological fields with 5+years of industry experience is required.

 

Experience and Skills:

Required:

  • Prior managerial experience with 3+ direct reports and is keen on staff career development is required.
  • Extensive experience developing, validating, and implementing ADA and NAb assays related to protein therapeutics, peptides, siRNAs, and ADCs is required.
  • Experience managing scientifically diverse teams of scientists toward execution of ADA and NAb assay development and validation is required.
  • Ability to provide scientific mentorship to staff is required.
  • Experience with regulated study bioanalysis and data reporting/interpretation is required.
  • Proficient in relevant regulatory guidance and with experience authoring regulatory document is required.
  • Ability to adapt quickly to changing needs of company and work collaboratively across functions is required.
  • Demonstrate excellence in method development strategies, data interpretation, strong assay troubleshooting ability, cross-function collaboration and communication is required.
  • Highly motivated, innovative, team-oriented mentality is required.
  • Excellent written and oral communication skills are required.

 

Preferred:

  • Experience in pharmaceutical drug discovery research is highly preferred.
  • GLP experience is highly preferred.
  • Experience with applications with a variety of cell based, biochemical and immunological assay platforms is preferred.
  • Experience in preclinical immunogenicity risk assessment is preferred.
  • Familiarity with automation platform is preferred.
  • Experience leading cross-functional teams or project teams is preferred.

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.

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.