Associate Director, Biologics Analytical Development

Johnson & Johnson•Malvern, PA

12h•Onsite

About The Position

The Associate Director, Process Analytical Sciences (PAS), is part of the Analytical Development (AD) Proteins organization and is responsible for accelerating large-molecule development by delivering phase-appropriate analytical testing at scale - combining high-throughput methods, automation, and streamlined data workflows to meet program timelines. This role is based in Malvern, PA.

Requirements

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.

Nice To Haves

Experience implementing digital laboratory solutions including ELNs, LIMS, CDS platforms, data visualization tools, workflow automation, and AI-enabled analytical processes.
Experience driving organizational change, digital transformation, or laboratory modernization initiatives.
Expertise in multiple analytical platforms including chromatography, electrophoretic techniques, bioassays, and characterization methodologies used for biologics development.
Track record of building high-performing organizations through coaching, mentoring, succession planning, and capability development.
Experience managing external collaborations, vendors, CROs, or strategic partnerships.

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.