Senior Expert Technical Development Lead

4 weeks ago


Cambridge, Cambridgeshire, United Kingdom Novartis Full time

Job Description

As a Senior Expert Technical Development Lead at Novartis, you will be accountable for leading Drug Product-related project activities within the Process Development line unit. Your key responsibilities will include managing a team of project sub-team members, acting as a project manager, and overseeing project activities. You will be responsible for owning the discipline project strategy in alignment with the technical development plan (TDP) and representing the project sub-team discipline in the CMC team as a core member.

Main Responsibilities

  • 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.

Requirements

  • 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 (PhD) 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


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