Associate Director, Biologics Analytical Development

Location: Hybrid, Malvern, Pennsylvania, United States

Company

Johnson & Johnson develops healthcare solutions and medicines through its Innovative Medicine and MedTech businesses.

What you will do

• Lead and develop a multidisciplinary team of analytical scientists supporting biologics drug development.
• Provide strategic and technical leadership for analytical activities from early development through PPQ, regulatory submissions, and commercialization.
• Oversee method development, qualification, validation, transfer, comparability, characterization, and routine testing across GMP and non-GMP environments.
• Lead laboratory operations, including capacity planning, prioritization, resource allocation, equipment utilization, compliance, and quality investigations.
• Drive digital transformation through electronic laboratory systems, data management, workflow automation, AI/ML applications, data visualization, and analytical platform integration.
• Support workforce planning, recruitment, succession planning, mentoring, performance management, and technical capability development.

Requirements

• Master’s degree or higher in Chemistry, Biology, Biochemistry, Engineering, or a related scientific or technical field.
• Minimum of 8 years of relevant industry experience.
• Leadership experience managing scientific teams in a matrixed pharmaceutical or biotechnology environment.
• Extensive experience with protein therapeutics, monoclonal antibodies, bispecifics, or other biologic modalities.
• Strong knowledge of analytical method lifecycle management, regulatory expectations, data integrity, GMP/GxP requirements, and quality systems.
• Experience collaborating with Manufacturing, Quality, Regulatory Affairs, Digital, and program leadership teams.

Nice to have

• Experience with ELNs, LIMS, CDS platforms, data visualization, workflow automation, and AI-enabled analytical processes.
• Experience leading digital transformation, organizational change, or laboratory modernization initiatives.
• Expertise in chromatography, electrophoretic techniques, bioassays, and biologics characterization methodologies.
• Experience managing vendors, CROs, external collaborations, or strategic partnerships.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and individual contribution.
• Opportunity to support the development of medicines from laboratory research through commercialization.
• Focus on scientific excellence, innovation, collaboration, and continuous improvement.
• Coaching, career development, succession planning, and technical growth opportunities.