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Scientist, Pharmacokinetics and Immunogenicity Assay Development

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Job Description


Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientist, Pharmacokinetics and Immunogenicity Assay Development in Janssen BioTherapeutics 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.

 

Essential Functions:

 

Janssen BioTherapeutics (JBIO) supports a wide range of therapeutic areas including Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, Infectious Diseases, and Pulmonary Hypertension. The Pharmacokinetics and Immunogenicity Assay Development group develops bioanalytical assays using various analytical platforms to characterize pre- and post-NME biopharmaceutical products in biological samples to support preclinical and clinical studies. As a Scientist, the candidate will have the opportunity to contribute to the discovery and development of novel biologic drug therapies by providing scientific and technical support on method development and study data interpretation. The candidate will develop fit-for-purpose bioanalytical methods using various technical platforms (e.g. immunoassay, qPCR, LC/MS-MS, etc.) based on project need to enable internal teams’ decisions with answers to critical questions related to PK/PD, mechanism of action, biodistribution, biotransformation, and matrix stability of biotherapeutic molecules.

 

The scope of this new position will include:

  • Representing bioanalytical function on discovery and pre-NME portfolio programs through membership on JBIO project teams.
  • Lead all scientific and technical aspects of bioanalytical method development activities to characterize PK and biodistribution for early discovery and development JBIO projects.
  • Interact with biologics discovery and therapeutic area colleagues to address key PK and bioanalytical questions and contribute to strategic discussions for lead candidate selection.
  • Interact closely with Discovery Translational Research group to develop bioanalytical formats and interpret study results to help assess in vivo PK/PD for biotherapeutic candidates.
  • Manage scientific and technical aspects of outsourced bioanalytical method development including scope of work generation, technical oversight, project timeline management, and bioanalytical data and study report review as well as establishing collaborative communication (e.g. F2F meetings, telecons, email, etc.) with external partners to provide timely and effective guidance related to ongoing project work
  • Accountable for the interpretation and presentation of complex data sets at cross functional team meetings as well as JBIO and Biologics Development Sciences (BDS) scientific discussions.
  • Coach and guide junior staff on scientific concepts and technical details of various bioanalytical methodologies.


Qualifications
  • PhD in Pharmacology, Molecular Biology, Biochemistry, or related degree with of 0-3 years or MS with 6+ years in pharmaceutical research and development is required

  • Strong scientific background and proven track record in bioanalytical method development using various platforms to support pharmacokinetic characterization for biopharmaceutical molecules is required

  • Excellent communication, interpersonal skills, and ability to work across internal or external teams in a matrix environment is required;

  • Ability to work with human and animal blood or biological tissue specimens is required;

  • Experience in quantitative qPCR methods is highly preferred;

  • Experience in large molecule LC-MS/MS (peptide quantitation and intact characterization) is highly preferred;

  • Experience in immunoassays/ligand binding assays is highly preferred;

  • Previous experience managing/directing outsourced vendor projects is a plus;

  • Background experience in CAR-T, oncolytic virus, and gene therapy platforms is a plus;

  • Must display an ability to independently design and execute method development with deep intellectual curiosity;

  • Ability to work under limited supervision with a high level of autonomy with good documentation and organization skills is 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-Spring House-Welsh & McKean Roads
Organization
Janssen Research & Development, LLC (6084)
Job Function
Pharmacokinetics
Requisition ID
7140191023