Associate Director, Biologics Analytical Development

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

People Leader

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

Job Description:

About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine.

We are searching for the best talent for an Associate Director, Biologics Analytical Development based in Malvern, PA.

Purpose:

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.

Your will be responsible for:

• 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.

Qualifications / Requirements:

Education:

Minimum of a Master's degree in Chemistry, Biology, Biochemistry, Engineering, or a related scientific/technical field is required

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.

Preferred:

• 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected under federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.