Associate Director, Biologics Analytics & Development

Johnson & Johnson Innovative Medicine; Malvern (Chester County); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Malvern, PA seeks an Associate Director, Biologics Analytical Development to accelerate large-molecule programs. The role leads a multidisciplinary analytical team, shaping strategy, and delivering phase-appropriate testing from early development through PPQ and readiness for regulatory submissions.

The successful candidate will partner with Manufacturing, Quality, Regulatory Affairs, and Digital teams, advancing automation, data integrity, and modern

Qualifications

• Minimum of 8 years of relevant industry experience.
• Proven leadership experience managing a scientific team in pharma/biotechnology.
• Extensive experience supporting analytical development for protein therapeutics, monoclonal antibodies, bispecifics, or other biologic modalities.
• Strong knowledge of analytical method lifecycle management, including development, qualification, validation, transfer, comparability, control strategy development, and regulatory expectations.
• Experience working across cross-functional organizations, including Manufacturing, Quality, Regulatory Affairs, Digital, and Program Leadership teams.
• Proven ability to lead complex projects, manage competing priorities, and deliver results across multiple development programs.
• Experience with laboratory operations, resource planning, budgeting, prioritization, and business management.
• Strong understanding of data integrity, GMP/GxP requirements, quality systems, and compliance expectations.
• Excellent communication, influencing, presentation, and stakeholder management skills.

Responsibilities

• Lead and develop a multidisciplinary team of analytical scientists supporting biologics drug development, fostering a culture of scientific excellence, innovation, collaboration, and continuous improvement.
• Provide strategic and technical leadership for analytical development activities supporting large-molecule programs from early development through late-stage development, PPQ, regulatory submissions, and commercialization.
• Contribute to analytical strategies for method development, qualification, validation, transfer, comparability, characterization, and routine testing activities across GMP and non-GMP environments.
• Provide leadership oversight for laboratory operations, including capacity planning, prioritization of testing activities, resource allocation, equipment utilization, compliance, quality investigations, and continuous improvement initiatives.
• Drive digital transformation initiatives involving electronic laboratory systems, laboratory data management, workflow automation, AI/ML applications, data visualization, and analytical platform integration. Partner with business and IT stakeholders to develop and implement scalable digital solutions.
• Lead organizational planning activities including workforce development, succession planning, recruitment, onboarding, training, and technical capability building to ensure sustainable business support.
• Sponsor innovation initiatives focused on automation, advanced analytics, laboratory modernization, data integration, and emerging analytical technologies to enhance efficiency and scientific capability.
• Mentor scientists and people leaders, providing coaching, career development guidance, performance management, and opportunities for technical and leadership growth.

Skills

Leadership

Team management

Stakeholder management

Communication

Project management

Influencing

Strategic thinking

Education

Master’s degree in Chemistry, Biology, Biochemistry, Engineering, or related field

Job description

Johnson & Johnson Innovative Medicine in Malvern, PA seeks an Associate Director, Biologics Analytical Development to accelerate large-molecule programs. The role leads a multidisciplinary analytical team, shaping strategy, and delivering phase-appropriate testing from early development through PPQ and readiness for regulatory submissions.

The successful candidate will partner with Manufacturing, Quality, Regulatory Affairs, and Digital teams, advancing automation, data integrity, and modern