Downstream 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:
As a member of our Technical Operations department you will participate in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of new biotechnology products. You will participate in manufacturing of biotechnology products in accordance with GMP principles and FDA requirements.
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 cooparation with Reaserch and Developmet Department/ Client;
- Running and monitoring the manufacturing process of biotechnology product accorrding to to GMP requirements, technological documentation and other internal requirements;
- Supporting of production team in aim of effective resources utilization, conducting the trainings;
- 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;
- Close cooperation with the MS&T, Production Operational Department and Quality Department;
- Participating in audits of suppliers of services and materials related to the production;
- Participation in invetigation for quality devaitaions and implementation of CAPA.
If you have:
- Minimum 2 years of experience in biotechnological or pharmaceutical industry;
- Good knowledge of cGMP and FDA requirements;
- Experience with recombinant proteins in production scale;
- Experience with protein purification processes;
- Knowledge of filtration and chromatography techniques;
- Very good speaking and writing English skills (level B2).