Senior Scientist, Proteins, Analytical Development (1 of 2)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

• Develop, validate, and transfer biochemical methods such as capillary electrophoresis (CE) and HPLC methods for characterization and quality control of biopharmaceutical products
• Serve as the analytical technical expert during method development, investigations, and regulatory inspections
• Seek and implement innovative technology and approaches for analytical method development to meet increasing analytical challenges for new modalities
• Lead one or more analytical projects and partner with process development scientists, analytical integrator, QC scientists to support programs ranging from early phase through late phase clinical development and commercial manufacturing
• Provide deep analytical expertise for programs ranging from early phase through late phase clinical development and commercial manufacturing
• Lead continuous improvement initiatives for methods, processes, and scientific procedures.
• Analyze and communicate complex data clearly and succinctly
• Write, review, and approve methods, validation/transfer protocols, technical reports, SOPs and present data to peers and functional management
• Author/review relevant sections of regulatory filings including but not limited to INDs, IMPDs and BLAs and address inquiries from the health authorities
• Contribute to improvement in laboratory operations to increase efficiency and GMP compliance

• Strong Biochemistry background
• Strong analytical problem-solving skills for developing creative, innovative solutions, and meeting project objectives
• Proven scientific expertise with extensive hands-on experience in protein isolation and separation techniques, including electrophoresis and chromatography
• Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters
• Excellent organization, communication, presentation skills and scientific/technical writing skills
• Excellent leadership, interpersonal, and negotiation skills with the ability to operate effectively in a dynamic work environment and collaborate with cross-functional teams

• In-depth large molecule Analytical Development experience with focus on Separation methods such as HPLC and capillary electrophoresis techniques
• Experience with commercialization of therapeutic proteins
• Must be meticulous, highly organized, and able to manage multiple tasks, handle tight timelines and deliver quality data
• Ability to make timely decisions and operate efficiently in times of ambiguity