LAVA Therapeutics generates and develops next generation γδ T cell engaging bispecific antibodies (gamma delta bsTCEs) 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 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 an (Associate) Director, CMC Operations.
As an (Associate) Director, CMC Operations you are part of the Chemistry Manufacture and Control (CMC) Development team. You work closely with internal and external project teams and CMC management.
- Organization of CMC development activities with a strong focus on Drug Product development which will lead to successful IND / IMPD / BLA / MAA submissions and subsequent market introduction of LAVA compounds.
- 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. The execution of the development work will be mainly done in a virtual environment by outsourcing the work to C(D)MOs and contract labs.
- Development of drug product formulations and presentations, the optimization and scale up of drug product manufacturing processes and the development of analytical methods into processes and methods to a level fit for commercial manufacturing.
- Maintenance of product development information repository to allow efficient retrieval of development reports, protocols, specifications and other relevant documentation.
- Design, manage, and interpret results in 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.
- Monitor and communicate progress on outsourced activities through internal project meetings and planning tools and present data at CMC meetings and to management.
- Represent LAVA’s interest in external project meetings.
- MSc or Ph.D. qualification in Biotechnology / Biology.
- Minimal 5-10 years of relevant work experience in late stage process development of therapeutic proteins with an emphasis on drug formulation and presentation forms.
- Scientific mindset.
- Excellent management skills with a clear overview on planned activities and with a strong drive to meet agreed timelines.
- You 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.
- Strong problem-identifying and trouble-shooting skills and a proven ability to learn and act on dynamic information at a rapid pace.
- Like to take initiative, enjoy working in a team and inspire others with your enthusiasm.
- Pay attention to detail and self-reflect on the quality of your work.
- Capable of working on several projects in parallel and prioritize appropriately.
- Able to travel domestically and internationally.
- Outstanding written and verbal communication skills in Dutch and English.
- Experience on analytical development/validation is regarded as a plus.
Working at LAVA
Our Core Values
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.
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 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 firstname.lastname@example.org referring to the (Associate) Director CMC Operations vacancy.
For more information about this vacant position, you can contact email@example.com. Your application and related information will remain strictly confidential.
Acquisition related to this vacancy is not appreciated.