Senior Expert Science & Technology

Job Description Summary

#LI-Hybrid
As a Cell Therapy Process Development Drug Product 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 for Drug Product in cross-functional CMC Team. You will have complete oversight of Drug Product related activities and retain accountability for DP-related project strategy and deliverables within your functional area.

 

Job Description

Accountabilities

• Lead the discipline sub-team, act as a project manager, and be accountable for all project activities within the Process Development Drug Product 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 DP 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.

• Compile and monitor critical raw material supply needed for development activities in scope of the project.

• Support Tech Transfer Lead in setting up transfer strategy and supports TT-related activities.

• Organize PD-PL project review meetings, updates project-specific risk-register and proposes relevant risk-mitigation strategies.

• Contribute and supports decisions for clinical manufacturing site selection and perform a technical fit gap analysis as needed

• Drive root cause investigations (RCIs) in his/her area of expertise

• Represent the PD functional area as an ad hoc member in early project teams (EPT), Global Program Teams (GPTs) or other boards, as required.

Requirements:

• Successfully demonstrated experience with cell therapy pharmaceutical development (Drug Product)- at least 5-6 years (BS), 2-4 years (MS) or 0-3 years (Ph.D.) of related

• 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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