Gene Therapy Process Sciences Drug Product Lead

Job content

To strengthen our new CMC Gene Therapy Process Development Department, based in Braine-l’Alleud, Belgium we are looking for a talented individual to fill the position of: Gene Therapy Process Sciences Drug Product Lead.

The Gene Therapy (GT) Process Sciences Drug Product Lead will be accountable for the drug product process development activities for UCB’s recombinant adeno-associated virus (rAAV) gene therapy portfolio.

This individual will be a people leader and will be accountable for the hiring and expansion of the drug product process development team. This role is an opportunity to build the organization and systems to drive forward UCB’s new gene therapy pipeline.

The Drug Product Lead will leverage internal and contract laboratories to support development of drug product processes and definition of an AAV production platform for UCB’s gene therapy offerings.

This role is a key scientific leader in the Gene Therapy organization at UCB. This individual will function remotely during the design and build of the new gene therapy development and manufacturing facility and then will move onsite (in Braine-l’Alleud) to support startup and operation of the development labs when the facility is online.

The successful candidate will be part of a team of process scientists and engineers supporting the establishment and operation of a development and manufacturing facility for gene therapy products.

You will more precisely contribute by:

• Acting as the drug product process development technical subject matter leader for rAAV gene therapy products, Quality-by-Design (QbD) process development, and pre-clinical and clinical manufacturing.
• Leading hiring efforts for the Drug Product Process Sciences team against hiring plans to support planned program scope and manage the team once hired.
• Planning, tracking, and reporting on progress against GT portfolio drug product development schedules.
• Acting as a representative of the drug substance and drug product development teams for integrated CMC technical solution teams.
• Authoring & reviewing technical documents including CMC regulatory sections, process descriptions, study designs, SOPs, technical position papers, & technical reports.
• Providing scientific leadership including experimental design and data analysis for the team internally, cross-functionally, and to partners and contract organizations (eg. CDMOs).

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

• PhD (Chemical engineering, Bioengineering, Biology, Biochemistry, Virology, or related field) with at least 3 years of experience OR master’s degree with at least 6 years of experience OR bachelor’s degree with at least 8 years of experience in BIOLOGICS process development, manufacturing, engineering or equivalent.
• Excellent technical knowledge of biologics drug product manufacturing and process development. Experience with AAV manufacturing is a strong asset.
• Experience in hiring and onboarding direct reports.
• Very good command in English and French, both spoken and written.

Soft skills:

• Strong people management and leadership skills.
• Project management, capacity modeling, and prioritization skills.
• Problem solving and drive for results.
• Interpersonal skills to communicate and maintain good working relationship with internal and external customers.

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.