Lead Scientist - Technology and Process Innovation (ref. ATP-2024-557)

KU Leuven Research & Development (LRD) builds bridges between science and society. As a technology transfer service of the KU Leuven Association, we guide scientists to put their research results at the service of society, the economy and the living environment. Our multidisciplinary team has a solid experience in setting up research collaborations, protecting and licensing intellectual property and establishing spin-offs. Through a unique network, we connect researchers with companies, but also with governments, investors and other organizations, so that we can respond together to the needs of society. In this way we are building a world ready for tomorrow, with today's excellent research. In the framework of the building of a unique translational hub named Multithera for the development and clinical translation of Advanced therapy medicinal products (ATMPs) LRD is looking for a lead scientist – technology and process innovation

Unit website

Responsibilities

The lead scientist will provide leadership and in-depth expertise in process development, analytics, and manufacturing of cell and gene therapies, with a specific focus on viral vector and cell therapy bioprocessing. This position requires engagement within the Multithera organization and the wider ATMP community itself (both local and international), as well as other stakeholders and collaborators. As a Lead Scientist, you will have the opportunity to manage key development programmes within Multithera’s portfolio and to guide its strategic priorities for future programmes. You will be responsible for designing projects and programs that cater to CGT industry requirements and ensuring the successful delivery of these projects through internal, commercial, and collaborative avenues.

Key responsibilities:

• Collaborate closely with internal and external stakeholders to oversee Multithera’s development programmes and its strategy for future projects;

• Lead and manage process development projects through technical supervision and cross-functional collaboration with subject matter experts;

• Maintain and continuously update your knowledge of the cell and gene therapy field to scope for Industry 4.0 advancements in the cell and gene therapy industry;

• Present data, strategy, and innovative developments to external stakeholders at conferences, webinars, and workshops.

Specific duties:

• Drafting, reviewing, and updating regulatory submission documents and supplemental applications, to ensure adherence to regulatory standards;

• Overseeing the transition from pilot to full-scale production, ensuring consistency and compliance with approved manufacturing processes;

• Managing the change control process for Chemistry, Manufacturing, and Controls (CMC) changes, evaluating their impact on product quality, and maintaining regulatory compliance;

• Monitoring manufacturing operations to ensure Good Manufacturing Practices (GMP) compliance and address any production-related issues;

• Planning and managing validation activities for manufacturing processes, analytical methods, and cleaning procedures;

• Delivering CMC-related training and guidance to internal teams and external partners/vendors;

• Identifying and implementing enhancements in CMC-related procedures and processes to increase efficiency and maintain compliance with evolving regulatory requirements.

Profile

• You have a Master or PhD degree in Biomedical Sciences; Pharmaceutical sciences; (Bioscience) Engineering or equivalent through experience;

• You have extensive experience in the biopharmaceutical or related industry, with a focus on Chemistry, Manufacturing, and Controls (CMC) for cell and gene therapy products;

• You have proven track record in managing CMC-related activities for drug development, manufacturing, and regulatory submissions;

• In-depth knowledge of Design of Experiments (DoE) implementation, Quality by Design (QbD), Good Manufacturing Practices (GMP), and other relevant regulatory guidelines;

• You have extensive experience in process development, scale-up, and validation for cell and gene therapy products;

• You have essential experience in technical transfer between commercial and research organizations;

• Strong understanding of analytical methods and their application in product characterization, release testing, and stability studies;

• You are familiar with regulatory submission requirements and experience in preparing CMC-related documents for INDs, NDAs, BLAs, and supplemental applications;

• You have experience in leading cross-functional teams and managing projects within a matrix environment;

• You possess strong problem-solving and decision-making skills, with the ability to analyse complex data and develop effective solutions;

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.

Your core competencies:

• Highly motivated and driven to support the growth of the cell and gene therapy industry, with a strong desire to build a successful career in the sector;

• In-depth understanding of Chemistry, Manufacturing, and Controls (CMC) requirements for cell therapies or biologics production;

• Ambitious, collaborative, and adaptable, with a positive attitude towards learning and professional development;

• Expertise in ATMP development and a broad understanding of other therapeutic modalities;

• Excellent interpersonal, communication, and emotional intelligence skills to build strong relationships with external stakeholders;

• Influential in developing relationships at all levels and understanding various perspectives to gain agreement;

• Confident public speaker with strong scientific credibility, both externally and internally;

• Takes responsibility for decisions and effectively balances strategic and operational requirements, supporting the organization's purpose;

• Adapts decision-making style based on available information, taking calculated risks when the potential rewards justify them;

• Committed to staying up-to-date with industry knowledge, expertise, and best practices;

• Willingness to travel.

Offer

• We offer a full-time position with a permanent role in an innovative environment in the center of Leuven;

• A salary matching the job responsibilities and taking into account your experience;

• Additional benefits including free hospitalization and group insurance, additional holidays, bicycle allowance, free public transport and ecocheques;

• A hybrid working environment and teleworking allowance.

Interested?

For more information please contact Mrs. Lieve Mommaerts tel.: +32 16 37 76 89.

You can apply for this job no later than November 26, 2024 via the online application tool