Scientific Director, Biotherapeutics Study Bioanalysis Team
Spring House, PA, USA | Johnson & Johnson
Job Description:51 people have viewed this job
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientific Director, Biotherapeutic Study Bioanalysis Team 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.
This is a scientific and operational leadership position within the Bioanalytical Sciences (BAS) group of the Biologics Development Sciences (BDS) department of Janssen Biotherapeutics. The BAS group is responsible for developing, validating, and conducting bioanalytical assays related to the biotherapeutic pipeline across all therapeutic areas of J&J, spanning non-clinical studies to post-market clinical development. This position requires technical leadership and managerial responsibilities for staff and/or temporary contractors for the execution of study phase bioanalysis and to represent BAS to various stakeholders such as JBIO project teams, Nonclinical Safety, Therapeutic Area lead Compound Development Teams, project managers, etc. The director will also support regulatory submissions across the therapeutic areas by writing the Summary of Biopharmaceutics and Associated Analytical Methods (SBAAM) documents for BLA submissions, the PK Written Summary documents for IND submissions and the responses to international Health Authority questions/information requests related to PK/ADA/PD methods and study results in alignment with company timelines.
Serve as the subject matter expert on the science and process of study bioanalyses; must effectively represent Bioanalytical Sciences (BAS) with Janssen stakeholders such as the Compound Development Teams and Disease Area Strongholds of the various Therapeutic Areas, Nonclinical Safety and Biotherapeutics Development Departments.
Contribute to defining bioanalytical strategy for a program/project/technology for the bioanalytical sciences group.
Lead the analysis of complex issues in biotherapeutic development and establish resolutions/decision points in a given program/project.
Drive the review and approval of bioanalytical related documents for scientific team(s) and health authorities.
Allocate and manage resources effectively, collaborate with other lab function groups to provide temporary resources to ensure Bioanalytical Sciences (BAS) is properly resourced (enabling a “flexible resourcing” model) to develop and validate assays and to analyze all non-clinical and clinical PK and ADA samples (from studies that support > 6 NMEs per year and > 50 programs from pre-portfolio through FIH), and when applicable, outsource work or hire new staff in a timely manner.
Perform assessments and provide recommendation on assays and immunogenicity risk in external due diligence projects, when assigned.
Expand external scientific visibility and reputation of J&J by actively participating in an appropriate professional society, drive impactful publications and lead scientific seminars and discussion forums.
PhD in Immunology or other relevant discipline
10-15 years business experience
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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