Combination Product Development Senior Specialist
Gdańsk
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your role:
As a Combination Product 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.
Your responsibilities:
- 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
If you have:
- 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