Gene Therapy Formulation Development Expert

工作内容

To strengthen the Analytical Team, based in our Gene Therapy Clinical Manufacturing and Process Development group in Braine-l’Alleud, Belgium, we are looking to fill the position of: Gene Therapy Formulation Development Expert.

This function will support the Adeno-Associated Virus (AAV) manufacturing processes and products with the aim of providing treatment to unmet medical needs through Gene Therapy (GT).

The Gene Therapy Formulation Development Expert has the responsibility of designing, selecting and characterizing Gene Therapy product formulations to support preclinical and clinical activities.

This is a growth opportunity that combines the excitement and opportunity of a start-up with the security and institution knowledge gained from working for a larger company.

Scope of the work:

• Design/optimize/characterize state-of-the-art viral vector formulations to ensure fit-for-purpose stability of bulk and vialed AAV-based Drug Product.
• Design/conduct development studies (e.g. developability assessment, robustness verification, short/long term stability, in-use/compatibility studies, …) and investigation studies (e.g. in case of OoS) to support non-clinical and clinical activities in accordance to the appropriate quality standard (e.g. data integrity (ALCOA)/GLP).
• Develop and perform analytical methods supporting formulation development activities.
• Design and execute experiments (DoE) to generate optimal and robust formulations.
• Build product understanding by connecting the impact of formulation parameters (buffer, excipient, surfactant, viral titer, …), stress conditions (light, oxygen, agitation, pumping,…) and physical degradation routes (aggregation, precipitation, denaturation, adsorption,…)
• Drive the implementation of quality and data-integrity compliant laboratory activities, which include laboratory set up, provision of technical resources, generation of SOPs, formulation and pre-formulation protocols/reports and any other related documentation.
• Independently analyze data, present results and conclusions.
• Support regulatory submission in reviewing CMC regulatory sections related to formulation development.
• Define the Gene Therapy formulation development landscape and establish integrated platforms with internal Gene Therapy partners (e.g. DP, delivery systems, process development, non-clinical toxicology, Early Solutions, Biological Formulation Development Sciences…)
• Develop external network (e.g. CLO, CDMO, industry forum, conference, …) to support formulation activities during process development, pre-clinical and clinical manufacturing.
• Support the development of the UCB GT strategy through, for example, building internal and external capabilities (i.e. CMOs/CROs/suppliers). The development of internal capabilities could, as an example, consists in contributing to the design/flows of future manufacturing/formulation lab areas.
• Strive for innovation and onboard new technologies: benchmark technical advances within the industry and evaluate their applicability to UCB candidates.

All these activities will be performed in respect of the material and premises, in compliance with the HSE/Biosafety/Data Integrity and GLP rules and with the regulatory requirements for each development phase of the product.

Initially, this position does not imply managing any direct report. However, there is a strong potential for future growth. Therefore, the ability to critically select and motivate talent, and coach team members in conducting research and development, analyzing results and documenting findings, will be important.

Interested? For this position you’ll need the following education, experience and skills:

• Phdpreferred but master’s degree may be sufficient based on experience.
• A previous experience in the pre-formulation /formulation/ drug product manufacture of Biologicals is required.
• A previous experience in a regulated laboratory (GLP/GMP) is a plus.
• Prior experience with viral vector-based formulation development and a strong understanding of virology and AAV biology is preferred.
• Strong and proven experience in the design/development of an analytical package to measure/control formulation development parameters (e.g. physico-chemical parameters (pH, osmolality, conductivity, viscosity, …), particle/aggregates characterization (light scattering techniques, HIAC, micro-flow imaging,…), compatibility with packaging/device components) and their impact on AAV degradation.
• Knowledge of statistical analysis principles used in Design of Experiments to efficiently optimize/characterize assays and to provide statistically meaningful outputs leading to the development of robust formulations.
• Good knowledge of English and ability to read, analyze, and interpret common scientific journals.

Soft skills:

• Proven project management skills.
• Ability to manage multiple programs in matrix environment.
• Ability to prioritize project work and make effective use of available resource to meet agreed timelines.
• Strong technical writing skills.
• Ability to author and approve comprehensive and accurate protocols/reports.
• Ability to select, implement and use appropriate data management concepts and tools.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills (identify problems, collect and analyze data, establish facts, and draw valid conclusions).
• Well organized, flexible, meticulous and rigorous (data integrity oriented).
• Ability to integrate new concepts and to work in a multicultural environment and to work efficiently and independently in a changing environment.
• Interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
• Team spirit oriented and able to offer/receive constructive feedbacks.

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.