Senior Expert Technical Development - Cell Therapy Process Development Project Lead

Job Description 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.

Job Description

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.

Minimum 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 (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

Work Experience :

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

Skills :

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

EEO Statement :

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives.

We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.

[email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information.

Please include the job requisition number in your message.

Salary Range

$124,000.00 - $186,000.00

Skills Desired

Coaching, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, Standard Operating Procedure (SOP), Technical Writing, Waterfall Project Management