Senior Principal Scientist, Bioanalysis

Location: Spring House, Pennsylvania, United States of America; onsite

Company

Johnson & Johnson MedTech develops healthcare solutions and innovative medicines across a broad range of therapeutic areas.

What you will do

• Own the end-to-end lifecycle of development PK assays, including development, validation, reagent qualification, stability programs, and data reporting.
• Design, optimize, troubleshoot, and lead investigations for immunoassays and chromatographic assays supporting biologics, oligonucleotides, ADCs, biomarkers, and emerging modalities.
• Prepare and review method reports, validation protocols, validation reports, and bioanalytical study reports.
• Provide scientific strategy and subject-matter leadership for regulated bioanalysis under GLP/GCLP, including updates to SOPs and practices.
• Support IND and BLA submissions, health-authority queries, assay transfers to external CROs, and cross-validation activities.
• Mentor scientific staff, evaluate emerging technologies, and communicate findings through presentations, publications, and conferences.

Requirements

• Ph.D. in Biology, Immunology, Biochemistry, Analytical Chemistry, or a related discipline with at least 8 years of relevant industry experience, or an MS with at least 10 years of industry experience in regulated bioanalysis.
• Deep hands-on expertise in ligand-binding assay development, optimization, validation, and troubleshooting for large-molecule bioanalysis, including MSD, Gyrolab, Quanterix, and ELISA.
• Experience developing assays for oligonucleotides, ADCs, biomarkers, and non-routine matrices such as tissues and CSF.
• Experience with critical reagent lifecycle management and laboratory automation or liquid-handling systems such as Hamilton, Scinomix, KingFisher, and Agilent Bravo.
• Practical GLP/GCLP experience, knowledge of global regulatory guidance including ICH M10, and proficiency with LIMS and ELN while maintaining data integrity.
• Strong scientific communication, project ownership, matrix leadership, and cross-functional collaboration skills.

Nice to have

• Experience mentoring scientific staff and building technical expertise in regulated bioanalysis.
• Experience with hybrid LBA-LC-MS, immuno-PCR, orthogonal bioanalytical approaches, and immunogenicity assay development.
• Experience supporting BLA and IND regulatory submissions.

Culture & Benefits

• Collaborative and regulated environment focused on developing treatments and improving patient outcomes.
• Inclusive workplace guided by Johnson & Johnson’s Credo and Leadership Imperatives.
• Equal employment opportunity and an inclusive interview process with accommodations available for applicants with disabilities.