Senior Principal Scientist, Bioanalytical Outsourcing

Senior Principal Scientist, Bioanalytical Outsourcing – Spring House, Pennsylvania, United States

Discovery & Pre-Clinical/Clinical Development

Pharmacokinetics & Pharmacometrics

Scientific/Technology

Purpose:

This scientific position is within the Bioanalytical Discovery and Development Sciences (BDDS) group, part of Preclinical Sciences and Translational Safety (PSTS). The role focuses on placing and managing bioanalytical assays at external organizations that support GLP and clinical-stage programs, with potential involvement in discovery-stage work.

• Comprehensive oversight of all bioanalytical assays—drug quantitation, immunogenicity (ADA and Nab), and soluble target engagement—across assigned programs and analytical platforms at external partners.
• Coordinate the review of supply agreements, protocols, reports, and regulatory filings as appropriate.
• Ensure all contractual obligations with external partners are met, monitoring deliverables, timelines, cost, and quality standards defined 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, resource needs, reagent issues, potential delays, and communicate timelines to J&J IM partners.
• Ensure validation activities are planned and completed and that CRO labs implement appropriate bioanalytical plans.
• Review data on a daily/weekly basis from CRO labs during study bioanalysis, confirm analysis and reporting schedules, troubleshoot issues, and provide resolution promptly.
• Communicate issues and mitigation strategies to partners and internal stakeholders.
• Collaborate with internal partners to prepare Data Transfer Agreements.
• Coordinate sample tracking and sample management processes, review central lab Statements of Work (SOW) for shipping schedules, and verify timely shipping of appropriate samples to J&J IM and/or CRO labs.
• Assist in reconciling shipping and sample issues; verify receipt of samples for each analytical effort.
• Track data reporting files from CROs, review for formatting and content accuracy, and ensure all study reports are received, reviewed, and archived by J&J.
• Support programs in China, preparing shipping permits for study reagents and ensuring compliance with HGRAO guidelines.
• Conduct onsite business reviews and scientific assessments of external CROs, evaluating partner laboratory capabilities and performance against BDDS standards.

• PhD with 6+ years post‑doctoral experience or Bachelor’s degree with 12+ years of working experience.
• Knowledge of the drug development process from discovery to BLA/NDA license application.
• Hands‑on expertise in bioanalytical ligand binding assays, including immunogenicity assays.
• Hands‑on expertise with LC‑MS/MS assays for small and large molecule therapeutics.
• Experience managing bioanalysis for clinical trials and GLP pre‑clinical studies.
• Strong problem‑solving skills, organizational habits, and excellent interpersonal communication.
• Ability to work under tight timelines and collaborate within multidisciplinary teams.
• Travel may be required, domestic and international, up to 20%.

• Well versed with Good Laboratory Practices, Good Clinical Practices, and worldwide regulatory guidance for bioanalytical method validation and immunogenicity assays.
• Excellent record keeping and communication skills.

Anticipated close: 4/22/2026. This posting may remain available through

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities under VEVRAA and Section 503 of the Rehabilitation Act.

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