Senior Biologics Analytical Development Scientist

Johnson & Johnson Innovative Medicine; Malvern (Chester County); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Malvern, PA seeks a Sr. Scientist to drive development, validation, and transfer of separation assays for protein biotherapeutics, including monoclonal antibodies and ADCs, to support clinical and commercial programs.

The role focuses on HPLC and capillary electrophoresis method development, regulatory submissions, and leading analytical projects with cross-functional teams in a GMP environment.

Qualifications

• PhD in Biochemistry or related field with 2+ years Pharma/biotech experience or MS with 5+ years or BS with 12+ years.
• Strong biochemistry foundation and hands-on protein isolation/separation experience.
• Excellent writing, communication, and leadership skills.
• GMP experience and regulatory submissions a plus.

Responsibilities

• Develop, validate, and transfer biochemical methods (HPLC, electrophoresis) for biopharmaceutical products.
• Serve as SME for method development, investigations, and regulatory inspections.
• Identify and implement innovative analytical technologies to address new modalities.
• Lead analytical projects and collaborate with cross-functional teams across development to commercialization.
• Provide analytical support to programs in early and late clinical development and manufacturing.
• Drive continuous improvement of methods, processes, and lab practices.
• Analyze complex data sets and present findings to technical and nontechnical stakeholders.
• Author/Review analytical methods, validation/transfer protocols, reports, and SOPs; present data to leadership.
• Contribute to regulatory submissions (INDs, IMPDs, BLAs) and respond to health authority inquiries.

Skills

Biochemistry

Analytical skills

Protein separation

HPLC

Capillary electrophoresis

Leadership

Communication

Regulatory knowledge

Data interpretation

Education

PhD in Biochemistry

MS in Biochemistry

BS in Biochemistry

Job description

Johnson & Johnson Innovative Medicine in Malvern, PA seeks a Sr. Scientist to drive development, validation, and transfer of separation assays for protein biotherapeutics, including monoclonal antibodies and ADCs, to support clinical and commercial programs.

The role focuses on HPLC and capillary electrophoresis method development, regulatory submissions, and leading analytical projects with cross-functional teams in a GMP environment.