Director, U.S. Development Pharmacokinetics Bioanalysis

Company: Disability Solutions
Location: Spring House
Posted on: September 19, 2023

Job Description:

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, U.S. Development Pharmacokinetics Bioanalysis 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. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information. The Director, U.S. Development Pharmacokinetics (PK) Bioanalysis will be responsible for the following:

• Provide scientific and operational support for PK assay development, validation and quantitative bioanalysis of preclinical (GLP) and clinical study samples at the United States based regulated Bioanalysis (BA) lab ensuring the timely delivery of GLP and clinical data.
• Ensure Good Laboratory Practice (GLP)/Good Clinical Practice (GCP) compliance.
• Continuously optimize operational performance, efficiency, and excellence of the lab (turn- around times, resource and instrument planning, documentation, implementation of new LIMS system, IT software strategy, automation, etc.).
• Enable the support of innovative and challenging bioanalytical applications for the modality-agnostic portfolio using LBA and LC-MS/MS technology; bring in innovative technologies where needed.
• Collaborate with the other groups within Bioanalytical Discovery and Development Sciences (BDDS): the regulated PK group in Belgium, reagent management, automation, immunogenicity and molecular biology, outsourcing and scientific pipeline management, discovery and compliance.
• Manage a team of managers (Principal Scientists) and actively grow and develop talent; lead an overall group of 18 people.
• Connect with stakeholders in non-clinical safety, Drug Metabolism and Pharmacokinetics (DMPK), Clinical Pharmacology, and Quality Assurance.
• Provide scientific visibility and recognition for Janssen through publications and scientific presentations internally and at major scientific and industry meetings.
• Be involved in due diligence bioanalytical assessments.
• Have a desire for learning and innovation, and continued career development.
• Be able to serve as a delegate to the Global Head of Development PK.
• Being the Operational Lead of the Development PK Bioanalysis group ensuring the timely, quality, and compliant delivery of GLP and clinical PK data.
• Hiring and managing of staff, planning for laboratory needs and workflows, and assuring prioritization of work targeted towards impactful portfolio projects.
• Anticipate future bioanalytical needs and develop proactive strategies and executable plans for assuring pipeline support.
• Member of the Global Development PK leadership team and potential to serve as a delegate to the BDDS leadership team contributing to strategic and long-range planning for BDDS and staff development/needs.
• Interface with leaders and peers in other R&D teams (e.g., Therapeutic Areas, Preclinical Sciences and Translational Safety, Clinical Pharmacology, Regulatory Affairs, etc.) as a thought leader and to provide ideas on portfolio, non-clinical safety, clinical, and regulatory strategy.
• Serve as BDDS representative to a therapeutic area portfolio governance.

Keywords: Disability Solutions, Philadelphia , Director, U.S. Development Pharmacokinetics Bioanalysis, Executive , Spring House, Pennsylvania