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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
Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.