Associate Director, Bioanalytical Integrator Team Lead
Spring House, PA, USA | Johnson & Johnson
Job Description:52 people have viewed this job
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, Bioanalytical Integrator Team Lead 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.
We seek an Associate Director within the Bioanalytical Sciences (BAS) group of the Biologics Development Sciences (BDS) department of Janssen Biotherapeutics (JBIO). The BAS group is responsible for developing, validating, and conducting bioanalytical (BA) assays related to the biotherapeutic pipeline across all therapeutic areas of J&J, spanning non-clinical studies to post-market clinical development. The Associate Director, Bioanalytical Integrator Team Lead serves as the responsible scientist for execution of study bioanalysis for assigned clinical programs and manages a team of bioanalytical integrators. The Associate Director (and team) develops BA strategies for all phases of clinical programs and oversees study BA timings. The Associate Director (and team) serves as primary BAS contact for interactions with internal JBIO functional teams (including Project Management, Trial Support and Laboratory Support) and biotherapeutic development teams [including Clinical Pharmacology and Pharmacometrics (CPP), clinical teams (CTs), cross-functional trial teams (CFTTs), Compound Development Teams (CDTs) and Chemistry, Manufacturing & Controls (CMC) teams] to ensure two-way communication of information critical for delivering regulatory submission-related projects. The Associate Director uses experience in bioanalytical sciences to guide the formation of bioanalytical strategies and resolutions of project related BA issues.
Ensure appropriate distribution of portfolio projects among bioanalytical integrator team members.
Provide guidance to staff to help resolve project management issues and use bioanalytical sciences background to help team resolve bioanalytical related challenges.
Develop BA strategies (e.g. selection of analytes, desired assay attributes, applicable matrices, and validation strategies etc.) for all phases of clinical programs.
Review and contribute to study protocol PK, target engagement, and immunogenicity sampling time points.
Educate biotherapeutic development teams on rationale for BA strategies, assay design, and experimental progress (as appropriate).
Serve as single point of contact for Clinical Trial Teams (for internal work) or to the appropriate partner representatives for collaborative studies (for external work), Project Managers and Compound Development Team (CDT) for bioanalytical related questions, concerns, issues, timelines, etc.
PhD in Immunology or other relevant field preferred
Proven experience in bioanalytical field and biotherapeutic development
Supervisor/people management experience is required
2+ years of People Management Experience
Experience in a GxP Environment
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
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