Senior Principal Scientist

Description

• Comprehensive oversight of all bioanalytical assays—including drug quantitation, immunogenicity (ADA and Nab), and soluble target engagement—across assigned programs and analytical platforms at external partners, ensuring seamless execution of bioanalytical activities from initiation through reporting.
• Coordinate review process of the supply agreements, protocols, reports, regulatory filings as appropriate.
• Ensure that all contractual obligations with external partners are met, including closely monitoring deliverables, timelines, cost, and quality standards as outlined in contracts. Submit and track status of work orders and change orders through internal business systems.
• Lead regular meetings with CRO labs to discuss bioanalysis progress, resources, reagent needs, issues, potential delays and communicate timelines and potential delays to J&J IM partners.
• Ensure appropriate validation activities are planned and completed along with appropriate bioanalytical plans are implemented by CRO labs.
• During study bioanalysis, review data on a daily/weekly basis from CRO labs. 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. Communicate issues to partners with risks and mitigation strategies.
• Collaborate with internal partners to prepare Data Transfer Agreements.
• Coordinate sample tracking/sample management process.
• Review central lab SOW to ensure sample shipping schedules are appropriate to J&J IM and/or CRO labs.
• Verify appropriate samples are being shipped to J&J IM and/or CRO labs on a timely basis.
• Assist in reconciliation of shipping and sample issues.
• Verify appropriate samples are received by J&J IM and/or CRO labs for each analytical effort.
• 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 J&J for review and archival.
• A portion of the responsibilities will be supporting programs in China. Candidate will be responsible for preparing shipping permits for study reagents and ensuring compliance with HGRAO guidelines.
• Work with BDDS leadership to conduct onsite business reviews and scientific assessments of external CROs, evaluating partner laboratory capabilities and performance against BDDS standards and expectations.

Qualifications

Education: PhD with 6+ years post-doctoral experience or Bachelor’s degree with 12+ years of working experience.

Required

• Knowledge of the drug development process from drug discovery to BLA/NDA license application.
• Strong expertise and hands-on experience in the bioanalytical application of ligand binding assays including immunogenicity assays.
• Strong expertise and hands-on experience with LC-MS/MS assays for small molecule and large molecule therapeutics.
• Experience with managing bioanalysis for clinical trials and GLP preclinical.
• The candidate will have a successful track record of problem solving, good organizational habits, excellent interpersonal skills, the ability to work under timelines, and the ability to collaborate within multidisciplinary teams is required.