Fill and finish Process 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
In this role you will plan, execute, interpret and document the experiments aimed at development of the fill and finish processes (including lyophilization) for final drug product. As an advantage you will also assist in troubleshooting at Drug Product Manufacturing.
Your responsibilities:
- Planning, execution, interpretation and documentation of experiments aimed development of the fill and finish processes (including lyophilization) for final drug product.
- Assistance in in troubleshooting at Drug Product Manufacturing
- Coordination of analytical activities and compilation of analytical documentation to support the
- Execution of experiments without supervision.
- Storing and managing data accordingto GDevP and internal procedures.
- Collaboration with other departments (USP, DSP, ADS, QC, QA, PP).
- Collaboration with IP department on formulation patent searches.
- Mentoring for junior staff.
- Writing reportsaccording 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:
- Higher education (biotechnology, analytical chemistry, biochemistry, pharmacy, or related)
- Experience in various characterization techniques used in biopharmaceutical R&D (e.g., HIAC, DLS, MFI, HPLC, UPLC).
- Experience in lyophilization process development (e.g., freeze-dryer, FDM, DSC, vacuum decay, KF) and scale-up as well as lyo formulation development
- Experience in finished drug product process development, especially aseptic – including mixing, pumping and filtration
- 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.
