Sr. Scientist, Biologics Analytical Development

Johnson & Johnson seeks a Senior Scientist for Biologics Analytical Development to develop, validate, and transfer separation assays for protein therapeutics. The role supports clinical and commercial development of monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates within the Proteins Analytical Development group.

Responsibilities

• Develop, validate, and transfer biochemical separation methods for biopharmaceutical characterization and quality control
• Lead analytical projects and serve as subject matter expert for method development and regulatory inspections
• Collaborate with process development, quality control, and cross-functional teams from early clinical through commercial stages
• Author and review analytical methods, validation protocols, technical reports, and regulatory submissions including INDs and BLAs
• Drive continuous improvement initiatives to enhance analytical methods, processes, and laboratory efficiency

Requirements

• Ph.D. in Biochemistry or related field with 2+ years pharma/biotech experience, or Master's with 5+ years, or Bachelor's with 12+ years
• Strong foundation in biochemistry and expertise in protein isolation and separation techniques
• Hands-on experience with capillary electrophoresis and HPLC methods
• Excellent analytical, problem-solving, communication, and technical writing skills
• Strong leadership, interpersonal, and cross-functional collaboration abilities
• Knowledge of method validation parameters, design of experiments, and regulatory guidance preferred