LAVA seeks a new team member:
Director CMC Operations
Lava Therapeutics (LAVA) is a start-up company that creates and develops next generation γδ T cell engaging bispecific antibodies for the curative treatment of cancer.
LAVA started its operations in 2017 and is advancing its proprietary platform and pipeline of bispecific therapeutic antibodies, building on cutting-edge research originating from Dr. Hans van der Vliet’s group at the VU University Medical Center and Cancer Center Amsterdam. In 2018, LAVA raised EUR 16 million in its first major institutional financing round that will allow LAVA to develop a lead candidate for clinical testing and broaden its pipeline and bispecific γδ T cell engager platform. Expanding our team with new, talented, employees is key to LAVA’s future success. The company is based in ‘s Hertogenbosch in The Netherlands.
As a Director CMC Project Operations you will be responsible for managing all CMC activities within LAVA. You will ensure that a manufacturing process (including formulation and fill & finish) is implemented and high quality (GMP grade) drug Product is available in time for testing. In addition you will be LAVA’s CMC representative for interactions with health authorities.
Qualified candidates will possess the following skills and experience:
MSc/PhD in Immunology, Pharmaceutical Sciences, Applied Sciences or related field
An innovative, goal-oriented, flexible and collaborative mindset
5-10+ years biotechnology industry experience
Strong analytical skills
CMC development experience in pharmaceutical or biotechnology drug development
Detailed knowledge of biopharmaceutical drug development and manufacturing/supply processes
Up to date on FDA and EU CMC regulatory requirements
Experience in CMC regulatory affairs with authoring and reviewing of CMC content for INDs/CTAs
Experience in interactions with Health Authorities
Track record of success as evidenced by sustained contributions in a biotechnology or pharmaceutical setting
Excellent communication skills and the ability to work as a team member
Proven ability to work with CMOs/external partners
Full time position
Permanent position after one year temporary contract
Salary and benefits according to biotech industry standards
T: +31 (0)73 627 4520-KvK 6533 5740-Onderwijsboulevard 225
5223 DE ’s Hertogenbosch
Responses to firstname.lastname@example.org