Executive Director, Head of Cell Line & Cell Culture Dev

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

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Job Function:

Enterprise Management

Job Sub Function:

Executive Management

Job Category:

People Leader

All Job Posting Locations:

Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

Johnson & Johnson -- 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

Role Overview

The Executive Director, Cell Line and Cell Culture Development is a senior scientific and people leader within Proteins Development - API, accountable for the global strategy, execution, and organizational leadership of mammalian cell line development and upstream process development across the protein therapeutics portfolio.

This role is accountable for fit‑for‑stage development of all protein‑derived molecules from early development through late‑stage development to commercialization, as well as providing deep technical and next‑generation process development support to commercial products as needed—ensuring robust, scalable, compliant, and cost‑effective processes that enable rapid portfolio progression and reliable patient supply.

The Executive Director operates as a key member of the Proteins Development – API leadership team, partnering across Proteins Development – API and beyond including Biologics Discovery Process Research, Biologics Development China Core, Drug Product Development and Delivery, Analytical Development, CMC, Quality, Regulatory, Manufacturing, Procurement, and J&J Innovative Medicine Supply Chain to deliver integrated solutions aligned with enterprise priorities.

Key Responsibilities

Scientific & Technical Strategy

• Define and own the global strategy to build, deploy, and continuously advance world‑class cell line, media, and cell culture platforms that remain competitive and fit‑for‑purpose across the portfolio.
• Ensure development approaches and work packages are fit‑for‑stage, platform‑aligned, and positioned to enable rapid clinical progression, best product and process at launch, and robust lifecycle management.
• Provide senior scientific leadership across cell line generation, clone selection, media and feed strategy, upstream process optimization, scale‑up, and process characterization.
• Serve as the enterprise subject‑matter authority for CLD and upstream development within CMC governance, portfolio, and technical review forums.

Program & Portfolio Delivery

• Ensure on quality, on time, and on budget cell line development and cell culture development in support of integrated CMC plans.
• Partner with Biologics Discovery Process Research and CMC program leadership to align scope, timelines, resources, and risk postures.
• Accountable for proactive identification and management of technical and operational risks related to cell line and cell culture development.
• Support technology transfer and GMP manufacturing readiness, including troubleshooting, deviation support, and continuous process improvement.

External Manufacturing & Partnerships

• Provide executive oversight of CDMO performance, ensuring delivery against technical, quality, compliance, and timeline expectations.
• Act as senior escalation point for complex issues involving external partners and manufacturing sites.

Regulatory & Quality Alignment

• Own cell line and cell culture–related regulatory strategy, ensuring phase‑appropriate content for IND, BLA, and global submissions.
• Partner closely with Quality and Regulatory Affairs to ensure development activities meet global regulatory and compliance expectations.
• Represent cell line and cell culture development in regulatory interactions as required.

People, Culture & Organizational Leadership

• Build, lead, and develop a high‑performing organization, including senior leaders and technical experts.
• Establish clear expectations and accountability for scientific rigor, delivery excellence, safety, quality, and budgetary compliance, and talent development.
• Drive a culture aligned with J&J CREDO, C.E.O Leadership Imperatives, emphasizing accountability, collaboration, inclusion, and continuous improvement.
• Ensure succession planning and capability building to support long‑term organizational sustainability.

Qualifications

Education

PhD in Cell Biology, Biochemistry, Chemical Engineering, Biotechnology, or related scientific discipline.

Experience

• 10+ years of experience in biologics CMC with deep expertise in mammalian cell line development and cell culture process development.
• Demonstrated leadership at Senior Director or Executive Director level within large pharma or advanced biotech organizations.
• Proven track record delivering upstream processes through clinical development and GMP manufacturing.
• Strong experience working within matrixed, global organizations and with external manufacturing partners.
• Demonstrated ability to influence senior stakeholders and operate effectively within enterprise governance models.

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 by 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 and 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, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills:

Budget Management, Business Continuity Planning (BCP), Competitive Landscape Analysis, Continuous Improvement, Corporate Management, Developing Others, Empowering People, Inclusive Leadership, Leadership, Managerial Courage, Operational Excellence, Performance Measurement, Stakeholder Engagement, Standard Operating Procedure (SOP), Strategic Analysis, Strategic Change, Vendor Management