Summary

As a Cell Therapy Process Development Project Lead (DP-PL) you will be accountable for Drug Product-related project activities. You will lead, manage, coach and support the project sub-team by fostering a culture of innovation, empowerment, trust, learning, diversity and inclusion. You will support the Novartis pipeline programs, representing Process Development function, operating as a single point of contact in cross-functional CMC Team. You will have complete oversight of Cell Therapy Process related activities and retain accountability for Process Development-related project strategy and deliverables within your functional area.

About the Role

Major accountabilities:

• Lead the discipline sub-team, act as a project manager, and be accountable for all project activities within the Process Development line unit.
• Own the discipline project strategy in alignment with the technical development plan (TDP) and represent the project sub-team discipline in the CMC team as a core member.
• Set priorities and objectives within the Process Development sub-team in alignment with the TDP and CMC objectives, and update the CMC team on technical issues, risks, and mitigation strategies.
• Oversee study design, provide guidance to functional leads (FLs), and ensure adherence to project development strategy.
• Track project progress according to defined timelines, identify roadblocks/risks and issues, develop solutions and mitigation plans/scenarios, and proactively report them to respective stakeholders and governance boards.
• Compile and provide financial forecasts for project-specific development activities needed to reach program milestones.
• Manage project-specific compliance aspects (e.g., change notifications, deviations).
• Assess, consolidate, and monitor resource needs and timelines for assigned projects.
• Ensure DP development is compliant with quality principles and cGMP practice.
• Stay at the forefront of scientific and technical trends in the discipline through literature and participation in conferences and workshops.

• University degree in biotechnology, pharmaceutical technology or similar discipline
• Successfully demonstrated at least 5-6 years (BS), 2-4 years (MS) or 0-3 years (Ph.D.) of related experience with cell therapy process development.
• Thorough understanding of cell therapy development processes, good knowledge of state-of-the-art cell therapy technologies & equipment, and knowledge of ATMP-related health authority regulations.
• Project excellence: Navigating through complexity and ambiguity, strong communication & presentation and organization and planning skills, excellent time management and planning abilities; inclusive in a decision-making process, strong leadership skills in a matrix set-up.
• Operational excellence: Demonstrates cross-functional problem-solving, critical data evaluation, continuous improvement mindset; advanced coaching and proven leadership skills.
• Organizational Savvy: Understanding organizational structures, working practices and strategy. Inclusive and collaborative across disciplines and geographies, excellent networking and relationship building.
• Stakeholder engagement: Excellent communication, negotiation, and interpersonal skills. Ability to work in interdisciplinary and cross-cultural teams; confident in managing expectations and conflict management.
• Business mindset: strategic thinking and planning, confident with risk management including quality & safety, resources and budget planning.
• Vision and Purpose: a role model to the functional team for creating a shared purpose; priorities and objectives setting

• People Challenges.
• Critical Negotiations.
• People Leadership.
• Operations Management and Execution.
• Collaborating across boundaries.

• Budget Management.
• Coaching Skills.
• Data Science.
• Experiments Design.
• Laboratory.
• Problem Solving Skills.
• Process Simulation.
• Project Management.
• R&D.

• English.