Expert in Viral Vector Manufacturing and Analysis, Leiden/NL

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The ‘make-it-happener’.

We are looking for an Expert Viral Vector Manufacturing and Analysis (Associate Director)

Scope of the job

As expert in the viral vector team, you are responsible for the technical and operational management of our rapidly expanding activities within our external network of viral vector suppliers. You team up with our suppliers and your Galapagos-colleagues to secure the viral vector supply, analytical characterization, quality control and regulatory filings to bring our innovative cell therapy products to patients.

Your role

As expert in viral vector manufacturing and analysis you will play a pivotal role in the cell therapy organization where your passion for CMC analytical development and management of external partnerships comes together.

Being responsible for viral vectors in our cell therapy environment means you employ your technical and negotiating leadership qualities to contribute to many different aspects of the drug development trajectory, particularly viral vector analytical development, quality control testing and late phase/commercial readiness; critical issue/risk identification, stability strategy, performance monitoring, analytical method validation and assuring timely critical material and product supply. You build strong and reliable relationships with contract development manufacturing organizations (CMO/CDMO) and contract testing labs (CTL) and align their deliverables with internal stakeholders to drive the viral vector strategies for our cell therapy programs. You also serve as Subject Matter Expert (SME) and author to enable the timely delivery of regulatory filings of early, late and validation phase documents and strategies.

Summary of key responsibilities

• Oversee analytical method development and validation for lentiviral vectors at our manufacturing partners (review of validation protocols, support tech transfers and trending batch analysis results, phase appropriate testing package definition)
• Support and advise on specification development and justification throughout the clinical phases of development and commercial, including alignment with the specifications of the cell products
• Act as stability study owner connecting externally executed stability studies to required internal storage strategies, documentation and in-use requirements for CAR-T manufacturing.
• Define processes and author SOPs to ensure embedding of critical LVV information from our suppliers to support dissemination to key internal stakeholders and support regulatory filing.
• Act as CMC project leader for one or more viral vector programs to ensure effective cross-functional coordination and alignment with CAR-T process development, clinical testing and other CMC functions.
• Support the selection of the best-suited partners to meet Galapagos’ strategic objectives, budget. Negotiate and establish the required contracts and work packages.
• Proactively cultivate and expand strong relationships for execution of operational activities with CMOs/CTLs/Partners to ensure robust and timely supply and analysis of viral vector(s)
• Planning/execution of gap assessments to drive viral vector development at CMO/CTL/Partner sites considering regulatory and jurisdictional control
• Collaborate with CDMOs and internal stakeholders on risk mitigation strategies, major technical issue resolution, and endorsing plans for continuous improvement
• Draft regulatory dossier sections in collaboration with external and internal partners

This role reports to the Head of Viral Vector Manufacturing and CMC within the GLPG Cell Therapy CMC organization and requires regular domestic and international travel.

• MS / PhD degree in life sciences, biotechnology, pharmacy or related discipline
• At least 7-10 years of experience in a biotech/pharma company, preferably coming from a senior/principal scientist role in analytical development, QC, or equivalent
• Knowledge and experience with (outsourced) analytical development, method transfer, method validation and stability studies for viral vectors
• Knowledge of lentiviral or other viral vector biology; ideally also with application to engineered T cells using viral gene delivery modalities
• Ability to drive and foster cross-functional and cross-company collaboration while representing the Viral Vector Manufacturing & CMC department and Galapagos, respectively.
• Demonstrated ability to write regulatory dossiers for early and late phase, able to define regulatory strategies for viral vectors
• Team-player, communicator capable of maintaining strong and positive relationships with internal and external stakeholders.
• Ability to be flexible with changing priorities, unexpected events
• Self-driven and can-do mindset, without compromising quality
• Fluent in English

What’s in it for you ?

You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos: together we can make it happen…!