DSP Senior Specialist
Duchnice
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:
Working with us you will have the responsibility for the specification and purchase, qualification of production equipment, participation in technology transfer in accordance with cGMP regulations and internal during the implementation of projects related to the introduction of new biotechnology products.
You will also take part of manufacturing of biotechnology products in accordance with GMP principles and FDA requirements to obtain a product of specified quality in the specification.
Your responsibilities
- Elaboration, verification design and qualification documentation. Participation during equipment and systems qualification.
- Elaboration of SOPs and manuals ( including manuals to equipment).
- Documentation preparation according GMP rules and internal company requirements.
- Attending during technology transfer, process validation in cooperation with Research and Development Department.
- Running and monitoring the manufacturing process of biotechnology product according to GMP requirements, technological documentation and other internal requirements.
- Supporting of production team in aim of effective resources utilization, conducting the trainings.
- Actual delivering supervisor or proper people reports and all necessary documentation to process evaluation.
- Informing direct supervisor about all abnormalities in process, documentation, progress of tasks and decisions.
- Report preparation of performed tasks
- Work organizing and impact on the work of others in order to make the most effective use of working time and performance of tasks
- Keeping documentation in accordance with the requirements of GMP
- Preparation and updating of system documents, procedures and instructions as well as related documentation in accordance with the GMP requirements
- Running the training for employees of the Production Department
- Close cooperation with the Quality Department
- Participating in audits of suppliers of services and materials related to the production
- Cooperation with all Production Department team and other groups from site and Polpharma Biologics
- Superior command execution
If you have
- Higher education (at least Msc) in Biotechnology, Pharmacy or similar.
- Good knowledge of cGMP and FDA requirements
- Experience in work with recombinant proteins and their purification. Performing monoclonal antibody purification process in production scale according to GMP rules.
- Good knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production
- Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required
- Very good speaking and writing English skills (level B2)
- Knowledge of MS Office