Principal Pharmaceutical Scientist - English
Our client is an innovative quantum technology startup that was spun off from the University of Ulm and is backed by tier-1 investors from Silicon Valley and Europe. Their mission is to leverage their unique know-how and IP in quantum technologies to become a front-runner in the development and commercialization of novel medical imaging modalities compounded at the point of care. This technology will advance the diagnosis and treatment of cancer, cardiovascular diseases and neurological disorders.
They are actively seeking a Principal Pharmaceutical Scientist (m/f/d) for taking a key role in the development of a compounding system that will be used at hospitals (at the point of care) to prepare innovative injectable MRI contrast agents.
What will be your key responsibilities:
- As a pharmaceutical expert, you will lead projects of innovative drug developments, including drug substances and products (injectables), analytical and process development, and participate in validation, control strategy, and technology transfer in accordance with US/EU pharmaceutical regulations.
- These activities are part of the global development of very innovative technology, combining quantum physics and sophisticated GMP compounding systems used at the point of care (Hospital).
- These activities will be done with the Director of Chemistry, the Device Development team, the CMC Manager, and top-tier CRO/CDMOs.
- You will have a key and decisive responsibility in establishing pharmaceutical and regulatory expertise, technical strategies, and best practices for their innovative drug products' formulation, process, and analytical developments.
- Building methodologies and experimental plans following Quality by Design to develop robust processes and formulations in deep collaboration with our research scientists, chemists, and engineers.
- Characterizing and optimizing impurity profiles in collaboration with our CMC and non-clinical experts.
- Helping to develop purification and sterilization processes (filtration) and their validations in collaboration with our engineering and CMC managers
- Bringing expertise on and leading analytical development, validation, and transfer with the internal chemistry team, CRO, and Users (Hospital).
- Leading process and stability validations and generating all necessary scientific packages for Module 3 and registrations.
- Participating in regulatory writing and interactions with health authorities under the supervision of Regulatory Affairs and CMC
- Being responsible for the management of technology transfer projects of our products to our CROs and CDMOs, as well as defining and negotiating work packages and contracts with them.
What experience should you have:
- Ph.D. in pharmaceutical and/or chemical sciences or a related ﬁeld - highly desirable.
- Over 10 years of professional experience in the industry working on pharmaceutical development and tech transfer in a GMP environment (US/EU).
- Strong scientiﬁc skills and mindset, strong skills in chemistry. Passion for experimental work related to innovative drug development.
- Expertise in drug substance and drug product pharmaceutical and analytical developments (small molecule, sterile, injectable, HPLC, GC, NMR).
- Demonstration of independent work and expertise in development of drug products, preferably with experience leading and managing projects involving research activity, and management of CDMOs.
- Experience in working in an international, interdisciplinary and cross-functional team of strong scientiﬁc experts.
- Experience in contrast agents, radiopharmaceuticals and/or drug-device combinations is considered a plus.
What do you get in return:
- You are taking a vital role in a cutting-edge startup with an excellent perspective for the future, broad freedom for bringing your ideas, and space for personal development.
- Be a part of an international and dynamic team with extensive experience in quantum research and developing healthcare products.
- An enjoyable working atmosphere with an open-door and hands-on mentality.
- Competitive compensation
- Permanent contract
- 30 days of vacation days
- Relocation package if needed
- Flexible hybrid working model