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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.

• 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.

• 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 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.

• 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.

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.

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