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As a Device Development Senior Specialist you will be responsible for planning, execution, interpretation and reporting of combination product development (biologics in pre-filled syringes and/or autoinjectors).
Yo will also authoring and reviewing the device-related regulatory documentation.
- Acting as Subject Matter Expert in combination product development (biologics in pre-filled syringes and/or autoinjectors)
- Authoring and reviewing the device-related regulatory documentation
- Supporting the planning of Human Factors studies
- Planning of experiments
- Execution of experiments without supervision
- Storing and managing data according to GDevP and internal procedures
- Collaboration with other departments (USP, DSP, ADS, QC, QA, PP)
- Be a mentor for junior staff
- Writing reports according to the internal procedures
- Presentation of experimental data during team and/or department meetings
- Literature search to address challenges or to seek improvements
- Degree in pharmacy, biotechnology, chemistry or other life science
- Minimum 3 years of experience in combination products/ medical devices
- Minimum 3 years of experience in pharmaceutical industry (ideally in research and development department)
- Deep understanding of combination product and device-related ISO standards as well as global regulatory requirements and guidance document
- Experience in functional testing of pre-filled syringes and autoinjectors
- Excellent organization with good writing skills to deliver reports on time and with appropriate quality
- Ability to perform literature search, draw conclusions, communicate and present effectively
- Ability to collaborate on cross-functional projects, e.g., with IT department.
- Ability to plan and execute experiments at scarce supervision and deliver results within required timelines and quality
- Pro-active attitude and willingness to learn and contribute to the development of the group. Ability to work independently as well as a strong team player
- Practical knowledge of MS Office and fluency in English is a must
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.