Upstream 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
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.
- Participation in technology transfer and process validation in cooperation with MS&T and external Clients.
- Running and monitoring the manufacturing process of biotechnology production according to GMP requirements, technological documentation and other internal requirements.
- Coordination of production team in aim of effective resources utilization, conducting the trainings
- Close cooperation with the MSAT, Production Operational Department and Quality Department
- Supervision over schedules related to the preparation of GMP documentation in the Production Department - e.g. procedures, qualification documents, etc.
- Supervision and issuance of system documentation in the Production Department
- Monitoring the progress of preparation for inspections and audits (external and internal)
If you have
- Higher education in Biotechnology;
- At least 5 years of experience in biotechnological or pharmaceutical industry;
- Good knowledge of cGMP and FDA requirements;
- Experience with mammalian cell culture. Additional advantage will be performing cultivation in production scale;
- Experience in keeping and reviewing process and project documentation; documentation according to GMP requirements;
- Excellent knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production will be additional advantage;
- Experience with recombinant proteins will be additional advantage;
- Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks;
- Fluent English.