Executive Director, Head of Cell Line & Cell Culture Dev

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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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 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 fitforstage development of all proteinderived molecules from early development through latestage development to commercialization as well as providing deep technical and nextgeneration process development support to commercial products as neededensuring robust scalable compliant and costeffective 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.

• Define and own the global strategy to build deploy and continuously advance worldclass cell line media and cell culture platforms that remain competitive and fitforpurpose across the portfolio.
• Ensure development approaches and work packages are fitforstage platformaligned 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 scaleup and process characterization.
• Serve as the enterprise subjectmatter authority for CLD and upstream development within CMC governance portfolio and technical review forums.

• 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.

• 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.

• Own cell line and cell culturerelated regulatory strategy ensuring phaseappropriate 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.

• Build lead and develop a highperforming 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 longterm organizational sustainability.

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

• 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 () 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