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Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Pharmacokinetics & Pharmacometrics
Job Category:
Scientific/Technology
All Job Posting Locations:
Spring House, Pennsylvania, United States of America
Job Description:
We are searching for the best talent for our Senior Principal Scientist, Bioanalysis to be located in Spring House, PA.
About Innovative Medicine
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
Purpose:
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.
Key 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.
Required:
- 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.
Preferred:
- 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.
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 as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
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Required Skills:
Preferred Skills:
Clinical Pharmacology, Clinical Trials Operations, Consulting, Drug Discovery Development, Industry Analysis, Pharmacodynamics, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Researching, Research Proposals, Scientific Research, Tactical Planning, Technical Credibility
