Sr. Scientist, Discovery Bioanalytical Outsourcing Manager

  • Anywhere

Company :
J & J Family of Companies

Location :
Spring House, Pennsylvania

Expiry Date :
Sun, 28 Mar 2021 23:59:59 GMT

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Description :
Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for a Senior Scientist, Bioanalytical Outsourcing Manager in the 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 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 is responsible for development of bioanalytical assays using various analytical platforms to characterize pre- and post-NME biopharmaceutical, cell and gene therapy products in biological samples to support preclinical and clinical studies. As a Senior Scientist, the candidate will have the opportunity to contribute to the discovery and development of novel biologic drug, cell and gene therapies through outsourced management of scientific and technical aspects for bioanalytical assay development, validation, and study data analysis to enable non-GLP studies. The candidate will help establish fit-for-purpose bioanalytical methods at approved external vendors using various technical platforms (e.g. immunoassay, LC/MS-MS, qPCR, etc.) based on project needs. The candidate will contribute to study design, provide data and interpretation to project teams in order to enable key decisions related to PK/PD, mechanism of action, and biodistribution of biotherapeutic molecules, cell/gene therapy products while helping to align overall bioanalytical workload with internal assay development teams and projected study timelines. The scope of this position will include: – Manage scientific and technical aspects of outsourced bioanalytical method development including scope of work generation, technical oversight, facilitating drug materials and reagent shipments, project timeline management, and bioanalytical data and study report review. – Establish collaborative communication (e.g. F2F meetings, telecons, email, etc.) with external partners to contribute to study design, protocol reviews, nonclinical BA strategies, prompt delivery of bioanalytical data and interpretation, and to provide timely and effective guidance related to ongoing project work and ensuring vendor accountability for completion of contracted deliverables. – Work closely with JBIO Business Development group to ensure communication of accurate budgets, timely and efficient receipt of vendor quotes, and placement of finalized contracts. – Establish go-to vendors in multiple global locations to ensure fast turnaround of high-quality data supporting discovery and non-GLP studies. – Investigate new external vendors for novel bioanalytical capabilities and process workflows to better support JBIO platforms and programs. – Interact closely with internal assay development teams to balance overall bioanalytical workload between internal and external resources to meet project timelines. – Provide timely and transparent communication with relevant internal teams (Discovery Translational Research, Non-clinical Safety, JBTs) regarding project updates. Qualifications – Minimum of Bachelors’ Degree with 10+ years of relevant experience required. PhD in Pharmacology, Molecular Biology, Biochemistry, or related degree with minimum of 3 years or MS with 8+ years in pharmaceutical research and development is preferred. – Proven track record in bioanalytical method development of biotherapeutics using various platforms (e.g. immunoassay, LC/MS-MS, etc.) to support pharmacokinetic characterization is required – Excellent communication, interpersonal skills, and ability to work across internal or external teams in a matrix environment is required; – Previous experience managing/directing outsourced vendor projects is highly preferred – Experience in quantitative qPCR methods is highly preferred – Experience in development of biomarker and immunogenicity assays is highly preferred – Experience/background in the discovery and development process for biotherapeutic molecules is highly preferred – Background experience in CAR-T, oncolytic virus, and gene therapy platforms is a plus – Ability to work under limited supervision with a high level of autonomy with good documentation and organization skills is required. – Approximately 10% travel for CRO site visits. 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 R & D Requisition ID W