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Etat Combination Product Development Senior Specialist

Firma: Polpharma Biologics miejsce pracy: Gdańsk

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!
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
Join our Team!
Why you should work with us
Contact us
career@polpharmabiologics.com


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Data dodania: 11-01-2022
Wyświetleń: 138