Production Process Expert
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:
In this role you will be responsible for supervision of the production process of biotechnological products in accordance with the current requirements. You will take part in improving and optimizing production processes by proposing changes and implementing solutions in cooperation
with the MS&T department and other plants of the Polpharma Biologics group. You will participate in technology transfer in accordance with cGMP regulations and internal SOPs during the implementation of projects related to the introduction of new biotechnology products. Also you will
participate in process validation, manufacturing of biotechnology products in accordance with cGMP principles and FDA requirements to obtain a product of specified quality in the specification.
Your responsibilities:
- Supervision and monitoring of the production process of biotechnological products in accordance with the principles of GMP, technological documentation and other internal requirements;
- Planning and initiating activities regarding production processes optimization;
- Participation in technological trials in accordance with the principles of GMP, technological documentation and other internal requirements;
- Participation in the technology transfer in terms of implemented manufacturing processes of active substance in the production area;
- Participation in the developing of pre-validation/validation strategy in alignment with process validation lead, including supportive studies;
- Participation in monitoring and continuous verification of the active substance manufacturing process;
- Review key documents & coordinate input for relevant registration documents for accuracy & completeness (as appropriate);
- Documentation preparation according GMP rules and internal company requirements;
- Acting as the owner of technical change in accordance with GMP change management processes for a new and / or improved product, equipment and process through implementation, validation in a GMP environment;
- Participation in investigation for quality deviations and implementation of CAPA;
- Participation in preparations and participation in external, internal, clients inspections / audits;
- Actual delivering supervision 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;
- Development and verification of equipment qualification documentation;
- Participation in the qualification of equipment and systems;
- Developing of SOPs and manuals (including manuals to equipment);
- Close cooperation with the MSAT, Production Operational Department and Quality Department;
- Cooperation with all Production Department team and other groups from site and Polpharma;
- Work organizing and impact on the work of others in order to make the most effective use of working time and performance of tasks;
- Running and / or supervising training for employees of the production department;
- Conducting training courses on the created documents and participation in obligatory training.
If you have:
- Higher directional education in one of the fields of biotechnology, biology, pharmacy, chemistry, chemical technology, chemical and process engineering;
- About 5 years of professional experience in pharmaceutical industry;
- Experience in working with recombinant proteins on a production or laboratory scale or in pharmaceutical industry;
- Nice to have knowledge of protein chemistry and related with that interactions and cell behavior, metabolism;
- Nice to have knowledge of techniques for the purification of recombinant proteins on a production scale;
- Experience in process validation;
- Experience in supervision and monitoring processes and developing documentation;
- Experience in equipment qualification processes in pharmaceutical companies;
- Good knowledge of EudraLex GMP and FDA requirements;
- Very good speaking and writing English skills;
- Skills: good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required.