Sr. Scientist, Biologics Analytical Development

Location: Malvern, Pennsylvania, United States of America; hybrid

Company

Johnson & Johnson MedTech develops healthcare solutions and innovative medicines across the spectrum of patient care.

What you will do

• Develop, validate, and transfer biochemical methods using capillary electrophoresis and HPLC for protein biotherapeutics.
• Support characterization and quality control of monoclonal antibodies, bi- and tri-specific antibodies, antibody-drug conjugates, and other therapeutic proteins.
• Serve as an analytical subject matter expert for method development, investigations, regulatory inspections, and health authority inquiries.
• Lead analytical projects and collaborate with process development, QC, analytical integration, and other cross-functional partners from early clinical development through commercialization.
• Author and review analytical methods, validation and transfer protocols, technical reports, SOPs, and regulatory submission sections.
• Drive continuous improvement in analytical methods, laboratory practices, efficiency, and GMP compliance.

Requirements

• Ph.D. in biochemistry or a related scientific field with 2+ years of pharmaceutical, biotechnology, or postdoctoral experience; or a master’s degree with 5+ years of pharmaceutical or biotechnology experience; or a bachelor’s degree with 12+ years of industry experience.
• Strong foundation in biochemistry and extensive hands-on experience with protein isolation and separation techniques, including electrophoresis and chromatography.
• Strong analytical, problem-solving, organizational, communication, presentation, scientific writing, leadership, interpersonal, and negotiation skills.
• Ability to collaborate effectively across functions in a dynamic environment and deliver high-quality data under tight timelines.

Nice to have

• Knowledge of method robustness, design of experiments, method design, and assay validation parameters.
• In-depth large-molecule analytical development experience with HPLC and capillary electrophoresis.
• Experience applying AI in analytical development and knowledge of advanced analytical technologies and ICH Q2(R2) and ICH Q14 guidance.
• Experience supporting commercialization of therapeutic proteins and improving laboratory operations.

Culture & Benefits

• Work in an environment focused on innovation, scientific excellence, urgency, leadership, and personal accountability.
• Collaborate with teams supporting medicines from laboratory development through commercial manufacturing.
• Inclusive work environment committed to equal opportunity and accessible interviewing.
• Hybrid work arrangement in Malvern, Pennsylvania.