Fill and Finish Process Development 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:
We are currently looking for a Specialist for the Fill and Finish Development Team. In this position, you will be responsible for planning, execution, interpretation, and documentation of experiments aimed at the development of the fill and finish processes for the final drug product. You will also assist in troubleshooting at the Drug Product Manufacturing Department.
Your responsibilities:
- Planning, execution, interpretation and documentation of experiments aimed at development of the fill and finish process (including lyophilization)
- Close cooperation with Drug Product Manufacturing on development and implementation of primary packaging fill and finish process, as well as to solve appearing manufacturing problems
- Mutual cooperation with Formulation Development Team at Drug Product Development Department
- Planning and executing of experiments, mainly without supervision, and storing and managing data according to GDevP and internal procedures
- Collaboration with other departments (USP, DSP, ADS, QC, QA, IP)
- Writing reports according to the internal procedures and presentation of experimental data during team and/or department meetings
- Mentoring for junior staff
If you have:
- Degree in pharmacy, biotechnology, chemistry, or other life sciences
- Minimum 2 years of experience in formulation/analytical laboratory/drug product manufacturing
- Experience in various biophysical characterization techniques used in biopharmaceutical R&D (e.g., UPLC, HPLC, DSC, DLS, Fluorescence spectroscopy). Experience in particle analysis techniques (e.g. HIAC, MFI) is desirable but not essential
- Experience in finished drug product process development, especially aseptic - including mixing, pumping, filtration, and lyophilization
- Excellent organization with good writing skills to deliver reports on time and with appropriate quality
- Ability to plan and execute experiments at scarce supervision and deliver results within required timelines and quality
- Proactive attitude and willingness to learn and contribute to the development of the group. Ability to work independently as well as a strong team player
- Fluent English