CMC Director

AstriVax is a privately held spin-off company from the KU Leuven, founded mid 2022 with a seed round of €30 million to bring our ambition to the next level.

We are building a first in class Plug & Play vaccine platform with a patented DNA based technology that launches self-amplifying live attenuated viruses on which additional targets can be added. The versatile technology of AstriVax can be used to develop a wide range of vaccines to prevent and treat infectious diseases, up to potential applications in oncology.

We aim to address major challenges in vaccinology by developing novel vaccines that are single dose (game changing in vaccine landscape), easy to produce and with reduced cold chain requirements. The live attenuated viruses being launched from our products induce a polyfunctional immune response which has the potential to address many unmet medical need targets.

YOUR ROLE

As CMC Director you are responsible for the overall CMC activities and deliverables of the company’s Plasmid Launched Live Attenuated Virus (PLLAV) platform as well as for the steering of the outsourced manufacturing and analytical activities. Your main responsibilities will encompass:

• Responsible for all CMC documentation to be submitted to the regulatory authorities.

• Responsible for the in-house and outsourced CMC activities in close collaboration with the other departments and CDMOs.

• Ensuring that product and process development activities are state-of-the-art and meet the stage-specific regulatory requirements.

• Practical/active execution of the daily activities for the listed responsibilities.

• Coordinate, overview and steer the outsourced manufacturing and analytical activities.

• Responsible for the final quality and timely delivery of the outsourced manufacturing and quality control deliverables. Be the main point-of-contact for the contractors.

YOUR PROFILE

• Master or PhD degree in life sciences or equivalent working experience.

• At least 10 years of practical CMC experience in the pharmaceutical or biologicals industry, experience in vaccines and/or nucleic acid technologies is a plus

• Excellent understanding of the technical drug development process, both from the manufacturing and analytical side.

• Strong track record in preparing CMC documentation and submissions to the regulatory authorities.

• Experience in working with and managing of contractors (CDMOs/CROs)

• Excellent writing and communication skills.

• Strong sense for detail, open and critical mind, high quality standards.

• Good leadership skills, able to listen, to negotiate, to decide.

• A real collaborative Team player with a hands-on can do and solution-oriented attitude.

WHAT DO WE OFFER

A stimulating, open and collaborative environment where every employee can make an impact. We believe that we can only achieve our goal if we work together. You’ll be part of a passionate and inspiring team that goes the extra mile to address major challenges in vaccinology. We foster a culture of learning, entrepreneurship and innovation. Together we build the company.