Senior Principal Scientist, Bioanalysis

About the role

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

The Bioanalytical Discovery and Development Sciences (BDDS) organization develops and validates bioanalytical assays, and conducts bioanalytical sample analysis across the entire J&J Innovative Medicines (JJIM) R&D portfolio from discovery through development. We are looking for an accomplished and innovative Senior Principal Scientist to join the Development PK team in BDDS, Spring House (SH) to serve as a scientific and technical leader in both ligand-binding assays (LBA) and LC-MS based bioanalysis supporting J&J portfolio projects spanning all modalities and therapeutic areas. This role combines hands-on laboratory contribution with scientific leadership, supporting diverse modalities (e.g., biologics, oligonucleotides, ADCs, and emerging therapeutic platforms) and guiding strategy for development-stage programs. This position is an individual contributor role requiring strong influence, mentorship, and matrix leadership across BDDS and cross-functional teams, with potential for growth in scope and responsibilities over time. This position offers an exceptional opportunity to make a significant impact on bioanalytical support across J&J portfolio within a highly collaborative and regulated environment.

Responsibilities

• Serve as Development PK Representative for assigned programs and assays, providing end-to-end accountability for the assay lifecycle, including assay developments, validations, drug stock and reagent qualifications, long-term stability programs, and data reporting.
• Design and develop robust immunoassays (primary focus) and chromatographic assays, lead assay troubleshooting efforts for complex bioanalytical challenges by applying logical, science-driven, and innovative solutions.
• Guide investigations, assess the impact of deviations, and make data-driven decisions while effectively communicating technical challenges to cross-functional stakeholders.
• Prepare and/or review key bioanalytical documents, including method reports, validation protocols, validation reports, and bioanalytical study reports, ensuring scientific rigor, quality, and compliance.
• Serve as a subject matter expert in immunoassay development and validation for large molecules and complex modalities under Good Laboratory Practices (GLP)/Good Clinical Laboratory Practice (GCLP). Maintain deep knowledge of evolving regulatory expectations, identify gaps in internal practices, and drive updates to SOPs and related documentation to ensure compliance and adoption of best practices.
• Influence bioanalytical strategy and contribute to scientific direction within BDDS and across development programs.
• Partner with BDDS Leads, project teams, and relevant functions to support regulatory submissions (e.g., IND and BLA) and address queries from health authorities.
• Collaborate with outsourcing team to support assay transfer to external CROs, including cross-validation activities and data reporting.
• Mentor and develop scientific staff, fostering technical excellence in immunoassay development and regulated bioanalysis, and enabling effective execution of method validation in alignment with SOPs and industry guidance.
• Identify, evaluate, and champion emerging technologies to enhance bioanalytical capabilities, particularly for complex and novel therapeutic modalities, while maintaining rigorous standards and compliance.