Senior Principal Scientist, Bioanalysis—Immunoassay & LC-MS

Johnson & Johnson Innovative Medicine; North Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Senior Principal Scientist, Bioanalysis to lead immunoassay and LC-MS based bioanalysis at Spring House, PA. The role combines hands-on lab work with scientific leadership, across large molecules and complex modalities, in a regulated environment.

You will drive assay development, validation, and troubleshooting, mentor staff, and influence BDDS strategy while supporting regulatory submissions and cross-functional programs.

Qualifications

• PhD (or MS with 10+ years in regulated bioanalysis) required.
• Extensive hands-on experience in immunoassay development and validation for large molecules.
• Proven ability to troubleshoot complex bioanalytical assays across modalities.
• Experience with GLP/GCLP and regulatory guidance (ICH M10).
• Strong data integrity, documentation, and cross-functional collaboration.
• Proven track record supporting regulatory submissions (IND/BLA).
• Experience with automation and lab systems (LIMS/ELN).

Responsibilities

• Serve as Development PK representative for assigned programs and assays.
• Design and develop robust immunoassays and LC-MS methods with troubleshooting.
• Prepare validation protocols, reports, and study reports.
• Mentor scientific staff and lead cross-functional collaborations.
• Influence bioanalytical strategy across BDDS and development programs.
• Support regulatory submissions and interactions with health authorities.
• Oversee assay transfers to CROs and data reporting.

Skills

Immunoassay development

LC-MS bioanalysis

Regulated bioanalysis

GLP/GCLP knowledge

Education

PhD in Biology/Immunology/Biochemistry/Analytical Chemistry

Tools

MSD

Gyrolab

Quanterix

ELISA

Job description

Johnson & Johnson Innovative Medicine is seeking a Senior Principal Scientist, Bioanalysis to lead immunoassay and LC-MS based bioanalysis at Spring House, PA. The role combines hands-on lab work with scientific leadership, across large molecules and complex modalities, in a regulated environment.

You will drive assay development, validation, and troubleshooting, mentor staff, and influence BDDS strategy while supporting regulatory submissions and cross-functional programs.