Johnson & Johnson Careers
Scientist, Scientific Outsourcing
Requisition ID: 7899190620
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientist, Scientific Outsourcing 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 technical position within the Bioanalytical Sciences (BAS) group within the Janssen Biotherapeutics (JBIO) organization. This group is responsible for developing, validating, and conducting bioanalytical methods with external partners to support continued development of large molecule biotherapeutic drugs. The primary focus for this position is to place and manage a set of assays at external organizations. As a Scientist you will be responsible for:
Complete oversight of the bioanalytical assays (pharmacokinetics, immunogenicity and neutralizing antibody) of all studies in support of a large clinical biotherapeutic program
Serve as single point of contact for all bioanalytical-related study multiple external partners to ensure smooth conduct of the bioanalytical portions of the collaboration studies from initiation to reporting.
Ensure review by key stakeholders for all proposed studies prior to initiation
Confirm review process of the protocols/supply agreements/regulatory filings as appropriate
Confirm all stakeholders are satisfied with protocols/supply agreements/regulatory filing process.
Manage contracts between Janssen and all external partners
Ensure all appropriate legal approvals are obtained for planned studies
Work with business operations, procurement and legal to determine costs for the assays to be incurred by collaboration partner and ensure these are communicated and agreed to by the collaboration partner
Lead regular meetings with CRO lab(s) to discuss bioanalysis progress, resources, reagent needs, issues, potential delays and communicate timelines and potential delays to Janssen partners
Ensure appropriate validation activities are planned and executed along with appropriate bioanalytical plans are executed by CRO labs
During study bioanalysis, review data on a daily/weekly basis from CRO lab(s). Confirm sample analysis and data reporting schedules.
Troubleshoot issues related to the bioanalytical conduct of the study and find resolution in a timely manner so as not to affect reporting or submission timelines.
Establish and Review Data Transfer Agreements
Oversee sample tracking/sample management process
Review central lab SOW to ensure sample shipping schedules are appropriate to Janssen and/or CRO labs.
Verify appropriate samples are being shipped to Janssen and/or CRO labs on a timely basis.
Assisting in reconciliation of shipping and sample issues
Verify appropriate samples are received by Janssen and/or CRO labs for each analytical effort.
Accountable for on-time delivery of bioanalytical data and reports to meet study and regulatory timelines.
Track data reporting files when provided by CRO and review for accuracy in formatting and content.
Ensure all study reports are provided by CRO labs, sent to Janssen for review and archival
- Typically, will have a Ph.D. degree (or equivalent) with 0-3 years post-doctoral experience or a minimum of 12 years of experience performing progressively advanced duties beyond a B.S. degree, or at least 3 years of experience performing progressively advanced duties at the Senior Associate Scientist level, or the equivalent training/experience.
- Knowledge of the biologic drug development process from drug discovery to biologics license application.
- Strong expertise in the bioanalytical application of ligand binding assays.
- Demonstrated understanding of the Good Laboratory Practices, Good Clinical Practices and worldwide regulatory guidance for bioanalytical method validation is required.
- Experience with clinical trials is preferred.
- Understanding of pharmacokinetics, immunogenicity assays and biomarkers is preferred.
- The ideal candidate will have a successful track record of problem solving, good organizational habits, excellent communication skills, the ability to work under timelines, and the ability to collaborate within multidisciplinary teams is required.
- Attends in-house seminars and participates in scientific meetings as appropriate to support team goals.
- Presents data and recommendations to outside consultants, at in-house research forums and at outside professional meetings.
- Hosts visiting outside scientists; likely to initiate and maintain external collaborations to advance specific projects.
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
United States-Pennsylvania-Spring House-Welsh & McKean Roads
Janssen Research & Development, LLC. (6084)