Formulation 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
In this position you will become a member of R&D department and you will be involved in projects related to the development of diverse formulations of our biosimilar products.
Your responsibilities
- Planning and execution of experiments
- Supporting drug product development strategy planning
- Collaboration with other departments involved in process/product development and further life cycle (e.g. Upstream, Downstream and Analytical Development Departments, Quality Control, Quality Compliance, Technical Operations)
- Collaboration with IP department on formulation patent searches and patent application preparation
- Supporting preparation of registration dossier
- Storing and managing data according to GDP and internal procedures
- Writing reports according to the internal procedures and best scientific writing practices
- Presentation of experimental data during team and/or department meetings
- Performing literature searches to address challenges or to seek improvements
If you have
- Degree in pharmacy, biotechnology, chemistry or other life sciences
- Minimum 3 years of track-record experience in biologics formulation development (liquid and lyophilized forms; most preferably in monoclonal antibodies field)
- Experience in early to late phase drug product development
- Experience in analytical characterization techniques used in biopharmaceutical R&D (e.g., DLS, SLS, DSC, FTIR, DSF, chromatography, UV-Vis, viscosimetry)
- Ability to independently plan and execute experiments and deliver results within required timelines and quality
- Excellent organization (incl. good writing) skills to deliver reports on time and with appropriate quality
- Effective communication and good presentation skills to update team members on the project progress
- Ability to perform literature searches and draw conclusions from it
- Pro-active attitude and willingness to contribute to the development of the group. Ability to work independently as well as a strong team player
- Ability to collaborate on cross-functional projects, e.g. with IT department
- Practical knowledge of MS Office and statistical software (JMP)
- Fluent English is a must