Senior Stability / Expert 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:
Acting as a Senior Stability Specialist in the Quality Control. Acting as a major contact point for topics related to stability study in a given project, from development to discontinuation of production. Coordinating analytical activities and compilation of quality documents on the stability of the intermediate and the final product. Managing analytical knowledge about a specific project in the context of stability studies, by communicating with all those involved in the project. Supporting the process of solving problems related to the subject of analyzes performed for the needs of stability studies.
Your responsibilities:
Drug Substance and Drug Product of biosimilars
- Performing paper and electronic data review associated with stability studies to ensure data integrity in the Quality Control.
- Ensuring proper management, compliance and integrity of Quality Control documents, such as stability: protocols, reports, results, methods, specifications etc.
- Supporting Quality Control in the implementation of new computerized systems, e.g. LIMS, regarding stability studies.
- Participation in activities improving processes related to stability studies to increase their efficiency.
- Supporting analytical project leads in topics related to the stability of intermediate and final product.
- Supporting investigation of quality records such as deviations, CAPA, Change Control, related to stability testing.
- Active communication of stability testing topics to relevant supervisors and their teams.
- Conducting training in issues related to stability studies.
- Participation in the preparation of Polpharma Biologics for pharmaceutical inspections and audits conducted by domestic and foreign regulatory bodies.
- Contact and cooperation with domestic and foreign regulatory authorities in terms of product stability and associated analysis.
- Monitors stability due dates and coordinate data transfer from vendors
- Drafts and reviews stability and analytical sections of IMPD/IND/NDA or related regulatory dossiers to support clinical and commercial programs
If you have:
- Higher education in biology, chemistry, pharmacy, biotechnology or related fields.
- Knowledge of GMP requirements, pharmaceutical laws and regulations for pharmaceuticals, especially for biopharmaceuticals.
- Minimum 7 years’ experience in regulated laboratory environment (preferred biotechnological lab).
- Very good knowledge of GLP and GDP rules.
- Punctuality regarding timelines, ability to prioritize tasks.
- Good organization of work and time.
- Fluent knowledge of English both, written and spoken.
- Very good knowledge of MS Office.
- Ability to solve problems independently and teamwork.
- Ability of analytical thinking