Senior Principal Scientist, Bioanalysis

Johnson & Johnson Innovative Medicine•Spring House, PA

3d•Onsite

About The Position

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.

Requirements

Ph.D. degree in Biology, Immunology, Biochemistry, Analytical Chemistry, or related discipline with a minimum of 8 years of relevant industry experience, or an MS degree with a minimum of 10 years industry experience in regulated bioanalysis.
Deep, hands-on expertise in immunoassay (LBA) development, optimization, validation, and troubleshooting for large molecules bioanalysis, with demonstrated proficiency across platforms such as MSD, Gyrolab, Quanterix, and ELISA.
Proven track record of successfully developing and troubleshooting assays for complex modalities including oligonucleotides, ADCs, and biomarkers, as well as experience working with non-routine matrices (e.g., tissues, CSF).
Experience in critical reagent lifecycle management, including generation, screening, characterization, and long-term performance monitoring.
Hands-on experience with laboratory automation and liquid handling systems (e.g., Hamilton, Scinomix, KingFisher, Agilent Bravo) to enable efficient and reproducible assay workflows.
In-depth knowledge of the principles of regulated bioanalysis, with practical experience working under GLP/GCLP and strong understanding of global regulatory guidance (e.g., ICH M10).
Proficiency in laboratory systems, including LIMS and ELN, with a strong commitment to data integrity and compliant documentation practices.
Strong verbal and written communication skills, with the ability to clearly convey complex scientific concepts, risks, and assay challenges to cross-functional stakeholders.
Proven ability to operate effectively in a matrixed environment, demonstrating leadership in scientific problem-solving, project ownership, and cross-functional collaboration.

Nice To Haves

Experience in training and mentoring scientific staff, with a demonstrated ability to build technical expertise in regulated bioanalysis.
Experience in hybrid LBA-LC-MS and immuno-PCR formats, including application of orthogonal or complementary bioanalytical approaches.
Experience in immunogenicity assay development and risk assessment.
Experience in regulatory submissions such as BLA and IND.

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.
Communicate scientific findings and results effectively through oral and written presentations within and beyond BDDS; contribute to publications and represent the organization at internal symposia and external conferences.
Integrate Johnson & Johnson’s Credo and Leadership Imperatives into scientific decision-making, team engagement, and overall execution.