We are currently looking for a Director Process Development.
Ethris, based in the biotech hub Planegg / Munich, Germany, is a technical innovator in the field of messenger RNA (mRNA) therapeutics, an emerging alternative to gene therapies and protein-based drugs.
The company has developed two proprietary technology platforms to enable the use of mRNA as a therapeutic agent: stabilized non-immunogenic mRNA (SNIM®RNA) for transcript therapy and lipidoid nanoparticle (LNP) delivery technologies for SNIM® RNA delivery.
We focus on the development of mRNA-based therapeutics and vaccines for the treatment of respiratory diseases. Our technology helps replace or supplement missing or non-functional proteins or introduce new proteins to modulate disease progression or symptoms. We are committed to bringing these new technologies to patients as soon as possible.
We are a therefore looking for a dedicated Director Process Development who will be responsible for optimization and improvement of the mRNA and formulation production processes for Ethris drug candidates.
You will be in charge of:
- Supervising the execution of formulation, compatibility, and process development studies to support phase appropriate development of Ethris platform technology
- Managing the technical evaluation of critical manufacturing process parameters and provide technical support for issues arising from ongoing manufacturing activities.
- Support the CMC team during technical transfer efforts, process validation, and manufacturing of drug substances and drug products at CMOs.
- Author/review appropriate development reports and documents for internal use and in support of regulatory filings and prepare regulatory submissions or other correspondence with agencies as a subject matter expert. Maintain awareness of regulatory CMC requirements.
- Proactively identify issues, risks, and opportunities; make recommendations for improvement, mitigation, or changes; and facilitate resolution of issues.
- Oversee and organize internal lab scale and pilot scale production activities
Your profile:
- PhD or engineer in chemistry, biochemistry, pharmaceutics, or closely related discipline with 3+ years’ relevant industry experience.
- Demonstrated knowledge and expertise in drug product development, formulation, process development, manufacturing, and regulatory CMC.
- You are open-minded and creative and enjoy developing new concepts and strategies
- Ability to effectively manage multiple projects.
- Proven leadership and problem-solving skills.
- Excellent communication and presentation skills and a good command of written and spoken English
As a highly innovative and growing company in the field of biotechnology, we offer an immensely interesting as well as demanding job in close collaboration with the company management. You will get the opportunity of a “steep learning curve”, quickly growing operational, strategic and personal skills as part of a highly motivated team. An open communication culture and working atmosphere combined with a strong team spirit contribute to our success.
Ethris, based in the biotech hub Planegg / Munich, Germany, is a technical innovator in the field of messenger RNA (mRNA) therapeutics, an emerging alternative to gene therapies and protein-based drugs.
The company has developed two proprietary technology platforms to enable the use of mRNA as a therapeutic agent: stabilized non-immunogenic mRNA (SNIM®RNA) for transcript therapy and lipidoid nanoparticle (LNP) delivery technologies for SNIM® RNA delivery.
We focus on the development of mRNA-based therapeutics and vaccines for the treatment of respiratory diseases. Our technology helps replace or supplement missing or non-functional proteins or introduce new proteins to modulate disease progression or symptoms. We are committed to bringing these new technologies to patients as soon as possible.
Working and living in Munich : Munich is a beautiful city in southern Germany that offers a particularly high quality of life and safety. The Munich area is considered one of the leading biotechnology hubs in Europe. Besides Ethris, the Munich area is home to around 350 companies that are active in the life science sector including roughly 130 small and medium-sized enterprises (SMEs). Most of these SMEs are spin-offs from Munich’s renowned academic institutions: Ludwig Maximilian University, Technical University, Max Planck Institutes of Biochemistry, Neurobiology, and Psychiatry, and the Helmholtz Center for Environmental Health.