Senior Biologics Analytical Development Scientist

6084-Janssen Research & Development, LLC Legal Entity; Malvern (Chester County); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Johnson & Johnson in Malvern, PA seeks a Sr. Scientist, Biologics Analytical Development to lead development, validation and transfer of separation assays for protein biotherapeutics, including monoclonal antibodies and antibody drug conjugates, to support clinical and commercial programs.

You will oversee method development, troubleshooting, and regulatory interactions, collaborate across cross-functional teams, and drive continuous improvement while ensuring GMP compliance and data integrity.

Qualifications

• Education requirements vary: PhD w/ 2+ years pharma/biotech experience OR MS w/ 5+ years OR BA/BS w/ 12+ years pharma/biotech experience.
• Strong analytical and problem-solving skills; ability to develop creative solutions and achieve objectives.
• Extensive hands-on experience with protein isolation and separation techniques (electrophoresis, chromatography).
• Excellent scientific and technical writing, communication, and leadership abilities.

Responsibilities

• Develop, validate, and transfer biochemical methods (capillary electrophoresis, HPLC) for QC of biopharmaceuticals.
• Serve as analytical SME for method development, investigations, and regulatory inspections.
• Identify and implement innovative technologies to address analytical challenges.
• Lead analytical projects and collaborate across cross-functional teams to support programs.
• Provide analytical expertise across early to late-stage development and manufacturing.
• Drive continuous improvement of methods, processes, and lab practices.
• Analyze data and present findings clearly to technical and nontechnical stakeholders.
• Author/review/approve methods, validation/transfer protocols, reports, and SOPs; present data to leadership.
• Contribute to regulatory submissions (INDs, IMPDs, BLAs) and health authority responses.

Skills

Analytical Reasoning

Biochemistry

Chemistry

Manufacturing, and Control (CMC)

Coaching

Consulting

Critical Thinking

Drug Discovery Development

Emerging Technologies

Molecular Diagnostics

Pharmacogenetics

Pharmacovigilance

Process Improvements

Quality Assurance (QA)

Relationship Building

Research Documents

Scientific Research

Technologically Savvy

Education

PhD in Biochemistry or related field

MS in related field with pharma/biotech experience

Bachelor's degree with 12+ years pharma/biotech experience

Job description

Johnson & Johnson in Malvern, PA seeks a Sr. Scientist, Biologics Analytical Development to lead development, validation and transfer of separation assays for protein biotherapeutics, including monoclonal antibodies and antibody drug conjugates, to support clinical and commercial programs.

You will oversee method development, troubleshooting, and regulatory interactions, collaborate across cross-functional teams, and drive continuous improvement while ensuring GMP compliance and data integrity.