Sr. Scientist, Biologics Analytical Development Full-time

Sr. Scientist, Biologics Analytical Development

Purpose: Therapeutics, Development, and Supply (TDS), Proteins Analytical Development (AD) group is seeking a Sr. Scientist to support our dynamic Analytical Development (AD) Separation Sciences team. The experienced and motivated Senior Scientist will be responsible for development, validation, and transfer of separation assays for protein biotherapeutics including but not limited to monoclonal antibodies, bi- and tri-specific antibodies and antibody drug conjugates to be used in support of clinical and commercial development. You will work and grow in an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability.

You will be responsible for:

• Develop, validate, and transfer biochemical methods, including capillary electrophoresis and HPLC, for the characterization and quality control of biopharmaceutical products
• Serve as the analytical subject matter expert for method development, investigations, and regulatory inspections
• Identify, evaluate, and implement innovative technologies and approaches to address emerging analytical challenges associated with new modalities
• Lead one or more analytical projects and collaborate with analytical integrators and cross-functional partners, including process development and QC scientists, to support programs from early clinical development through commercialization
• Provide analytical expertise to support programs across early- and late-stage clinical development and commercial manufacturing
• Lead continuous improvement initiatives that enhance analytical methods, processes, and laboratory practices
• Analyze complex data sets and communicate findings clearly and concisely to technical and nontechnical stakeholders
• Author, review, and approve analytical methods, validation and transfer protocols, technical reports, and standard operating procedures; present data to peers and functional leadership
• Author and review sections of regulatory submissions, including INDs, IMPDs, and BLAs, and respond to health authority inquiries
• Contribute to laboratory operational improvements that increase efficiency and maintain compliance with Good Manufacturing Practices (GMP)

Qualifications/Requirements:

Education Required:

• Ph. D. in Biochemistry or a related scientific field with 2+ years of Pharma/biotech industry or post-doctoral experience OR a Master's degree with 5+ years of Pharma/biotech industry experience OR Bachelor's degree with 12+ years Pharma/biotech industry experience.

Experience and Skills:

Required:

• A strong foundation in biochemistry is required.
• Strong analytical and problem-solving skills, with the ability to develop creative solutions and achieve project objectives, are required.
• Demonstrated scientific expertise and extensive hands-on experience with protein isolation and separation techniques, including electrophoresis and chromatography, are required.
• Excellent organizational, communication, presentation, and scientific and technical writing skills are required.
• Excellent leadership, interpersonal, and negotiation skills, with the ability to work effectively in a dynamic environment and collaborate across functions, are required.

Preferred:

• Knowledge of method robustness, design of experiments (DoE), method design, and assay validation parameters is preferred.
• In-depth experience in large-molecule analytical development, with an emphasis on separation methods such as HPLC and capillary electrophoresis, is preferred.
• Experience applying AI in analytical development, knowledge of advanced analytical technologies, and familiarity with relevant regulatory guidance, including ICH Q2(R2) and ICH Q14, are preferred.
• Experience supporting the commercialization of therapeutic proteins is preferred.
• Meticulous attention to detail, strong organizational skills, and the ability to manage multiple priorities, meet tight timelines, and deliver high-quality data are preferred.
• The ability to make timely decisions and operate effectively amid ambiguity is preferred.

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.