‘s Hertogenbosch – (Associate) Director CMC Operations

The company
Lava Therapeutics (LAVA) generates and develops next generation γδ T cell engaging bispecific antibodies for the 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 the VU University Medical Center / Cancer Center Amsterdam. In the Netherlands the company is now located at the Science Park in Utrecht and at the Agrifood Plaza building in Den Bosch. Expanding our team with new, talented employees is key to LAVA’s future success. We are currently looking for a

(Associate) Director CMC Operations

The position
As an (Associate) Director CMC Operations you are part of the CMC Development team. You work closely together with internal and external project teams and CMC management. You will be responsible for the organisation of late stage CMC development activities for both Drug Substance and Drug Product which will lead to a successful BLA/MAA submission and subsequent market introduction of LAVA-compounds. The execution of the development work  will be mainly done in a virtual environment by outsouring the  work to C(D)MOs and contract labs. You coordinate the technology transfer of early phase processes/products to C(D)MOs while keeping a focus on the scientific understanding of our products and processes. You manage the optimization and scale up of early phase manufacturing processes and the development of analytical methods into processes and methods to a level fit for commercial manufacturing.  You will be responsible for the product development information repository to allow efficient retrieval of development reports, protocols, specifications and other relevant documentation. You design, manage, and interpret results coming from activities on process optimization/scale up/characterization and validation, together with our external partners. In close collaboration with our Regulatory representative you will drive authoring of CMC related CTD sections which will lead to a successful BLA/MAA. You monitor and communicate progress on outsourced activities through internal project meetings and planning tools and present data at CMC meetings and to management and will represent LAVA’s interest in external project meetings.

You have an MSc or PhD qualification in Biologics/Biotechnology with a minimum of 5-10 years of relevant work experience in late stage process development with a focus on transfer/scale up/characterization and validation of biotechnical manufacturing processes of therapeutic proteins. Experience on analytical development/validation and/or formulation is regarded as a plus. Next to having a scientific mindset, you are an excellent manager with a clear overview on planned activities and with a strong drive to meet agreed timelines. Your like to set up and maintain contacts with new and existing parties in which you get things done on time while keeping a good relationship. You have strong problem-identifying and trouble-shooting skills and a proven ability to learn and act on dynamic information at a rapid pace. You take initiative, enjoy working in a team and inspire others with your enthusiasm. You pay attention to detail and self-reflect on the quality of your work. You are capable of working on several projects in parallel and prioritize appropriately. You are able to travel domestically and internationally. Finally, you have outstanding written and verbal communication skills in Dutch and English.

The offer
A full time position. A set of excellent labour conditions. A permanent position after one year of temporary contract and a positive appraisal. Salary and benefits according to biotech industry standards. The location of the position will be at LAVA’s office in Den Bosch for at least 60 % of the time.

Working at LAVA
LAVA Therapeutics offers an attractive set of labour conditions, recognizing and rewarding its talented and motivated employees. This includes the ability to work together with a group of highly experienced leaders and professionals, who all have a track-record of success in their field of business and in Life Science industry. We offer flexible working hours, a premium-free pension plan, 30 paid vacation days, opportunities for growth and development and a professional working environment, in which hard working is balanced with fun.

Our Core Values
Our company culture is built on five important Core Values: Innovation, Teamwork, Results-orientation, Flexibility and Fun. We understand that innovation is at the heart of what we do. We drive the ability to innovate and we all have a strong awareness about emerging scientific and business opportunities. We work closely as a team, have a constructive and collaborative mindset and we put the common interest of the company above our own individual interest. We have a strong orientation on results, we meet agreed goals in a timely and efficient manner and we deliver on our promises. We are flexible, adapt well to changing circumstances and work well under pressure. Finally, we all contribute to a safe, professional and enjoyable workplace in which people are treated respectfully and diversity is embraced.

How to apply
Please send your CV together with a cover letter to referring to the (Associate) Director CMC Operations vacancy.

For more information about this vacant position, you can contact Peter Machielsen (Sr. Director CMC Operations) at  Acquisition related to this vacancy is not being appreciated.

Your application and related information will remain strictly confidential.