Director, U.S. Development Pharmacokinetics Bioanalysis
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.
- A minimum of a Bachelor’s degree in Chemistry, Biochemistry, Biology, or a related scientific discipline (e.g., Microbiology, Bioengineering, etc.). Advanced degree (Master’s, PhD) in a scientific discipline is preferred.
- A minimum of 15 years of drug development experience in a pharmaceutical setting with a Bachelor’s degree; a minimum of 12 years of drug development experience in a pharmaceutical setting with a Master’s degree; or a minimum of 9 years of drug development experience in a pharmaceutical setting with a PhD degree is required.
- A minimum of 5 years of people management experience is required.
- Proven track record in leading complex scientific and laboratory teams is required.
- Experience managing a large group of people (10+) is preferred.
- Experience managing a regulated bioanalytical laboratory is required.
- Prior Good Laboratory Practice (GLP) experience is preferred.
- Prior hands-on bench-level experience and the ability to help with method development and troubleshooting in the lab is required.
- Experience with RNA, gene, and/or cell therapies is preferred.
- Knowledge of overall drug discovery and development is required.
- Familiarity with current bioanalytical regulatory guidelines is required.
- Previous experience authoring and reviewing bioanalytical reports and submission documents and responding to health authority questions is required.
- Strong scientific and technical skills (LBA, LC/MS assays) required.
- Strong scientific/technical writing skills required.
- Knowledge of modern analytical capabilities, instrumentation, automation, software and data analysis tools/programs required.
- Must have excellent communication, interpersonal and networking skills.
- Must have exceptional leadership, diplomacy, and negotiating skills.
- Must have the ability to apply sound scientific methods to problems as they arise.
- The ability to build an effective team, set strategy, deliver results, and attract, develop, and retain diverse talent is required.
- The ability to collaborate with all levels and influence decision-making in a matrix environment is required.
- This position will require up to 10% domestic and international travel.
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.