Biologics Analytical Development Leader

Biopharma Careers; Malvern (Chester County); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson in Malvern, PA is seeking an Associate Director, Biologics Analytical Development to lead a multidisciplinary team within the Analytical Development Proteins organization, accelerating large-molecule programs from early development through commercialization.

You will provide strategic leadership for method development, qualification, validation, transfer, and comparability, while driving digital transformation, data integrity, and GMP/non-GMP compliance across programs.

Qualifications

• Minimum of a Master's degree in Chemistry, Biology, Biochemistry, Engineering, or a related scientific/technical field is required
• Minimum of 8 years of relevant industry experience
• Demonstrated leadership experience managing a scientific team and developing talent within a matrixed pharmaceutical or biotechnology environment
• Extensive experience supporting analytical development activities 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

Cross-functional

Communication

Stakeholder management

Project leadership

Education

Master's degree in Chemistry, Biology, Biochemistry, Engineering

Tools

ELNs

LIMS

CDS platforms

Data visualization tools

AI-enabled analytics

Job description

Johnson & Johnson in Malvern, PA is seeking an Associate Director, Biologics Analytical Development to lead a multidisciplinary team within the Analytical Development Proteins organization, accelerating large-molecule programs from early development through commercialization.

You will provide strategic leadership for method development, qualification, validation, transfer, and comparability, while driving digital transformation, data integrity, and GMP/non-GMP compliance across programs.