Oorspronkelijke vacature omschrijving:

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Project Lead, Commercial Programs will manage successful advanced development of late-stage cell and gene therapy products including transition from early phase development, technology transfer, validation (PPQ), submission and launch. This covers end to end all necessary technical , regulatory, quality, etc. aspects, which are required for a successful commercial launch of a product in collaboration with all disciplines

Position to be located preferably in Netherlands or Houston, Texas USA

Key responsibilities:

• Develops together with internal and client stakeholders a sound strategy for commercialization leading to an integrated project plan that the team will execute against.
• Creates and implements project definitions, schedules, budgets, resource plans and objectives for late-stage cell and gene therapy product development program or multiple projects of high complexity across multiple sites.
• Responsible for the design and implementation of Chemistry, Manufacturing and Control (CMC) development, tech transfer and validation plans compliant with applicable current regulations and guidance (e.g. US Food and Drug Administration, European Medicines Agency (EMA) and the International Committee on Harmonization (ICH)).
• Provides technical expertise to and oversight of Lonza’s program team, including project management, process development, raw material characterization and qualification, sterility assurance, assay development and qualification/validation for raw materials, IPC and DP testing, process validation (PPQ) and justification for CPP/CQA, stability studies, any additional aspects relevant for quality assurance, quality control, supply chain and logistics, regulatory affairs and external testing organizations in regards to all CMC activities supporting the advanced development of a product through validation and commercialization.
• Leads technology transfer (if applicable), manufacturing process development and optimization, analytical method development, optimization and qualification, manufacturing, validation (process and analytical), material management and preparation of all source documentation required for regulatory submissions.
• Maintains a risk log for the program and develops, recommends and implements risk mitigation solutions.
• Maintains a project Gantt chart in line with the Lonza CGT New product introduction procedural framework and conducts defined stage gate reviews.
• Provides ongoing reviews of the project status and identified risks of the project to internal and external stakeholders.
• Determines the need for and impact of changes in scope of project and makes and implements recommendations based on determinations.
• Works in conjunctions with team members and stakeholders to anticipate and manage changes to projects, such as but not limited to, technical requirements, business requirements and schedule
• Oversees all technical interactions between the customer and Lonza and works in close collaboration with Account and Program Management to manage overall relationship.
• Manages customer’s project management, company management and project team expectations for agreed upon project performance by obtaining and providing project metrics.
• Manages technical team with regard to all aspects of PAI readiness and during PAI.

Key requirements:

• Bachelor’s Degree in Scientific Discipline. Master degree preferred
• Highly proficient in global program and project management within CDMO organization
• Proven experience influencing cross-functional teams in a highly matrixed environment

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.