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USP Microbial Plant Junior Specialist

USP Microbial Plant Junior 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!
Your role

Participation in the production of biotechnological products in accordance with GMP rules and FDA requirements in order to obtain a product of the quality set in the specification, for registration, preclinical research and implementation on a semi-technical scale. Participation in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of new biotechnological products.        

Your responsibilities
  • Analyzing the obtained process results in terms of compliance with technological documentation and internal requirements.
  • Participation in technology transfer, process characteristics and process validation in cooperation with the Research and Development Department and Manufacturing & Science Technology MS&T Department.
  • Ongoing provision of reports and all necessary documentation to the supervisor and/or appropriate persons to evaluate the process.
  • Informing the immediate supervisor about any irregularities and potential delays in the process, documentation, as well as the status of the tasks performed and decisions taken.
  • Monitoring the process of manufacturing biotechnological products in accordance with the technological documentation.
  • Carrying out the process in accordance with the principles of GMP and other internal requirements.
  • Preparation of documentation in accordance with the principles of GMP and internal company requirements.
  • Reporting the progress of all work and status of performed tasks to the immediate supervisor.
  • Representing the company well.
  • Preparation of reports on performed tasks.
  • Securing the workplace.
  • Organizing work in order to make the most effective use of working time and complete tasks.
  • Cooperation with all teams of the Technical Operations Department and all other departments.
  • Developing model procedures and instructions and conducting training on them.
  • Preparation of equipment qualification documentation, conducting qualifications and/or participation in conducted qualifications.
  • Development of operating instructions for devices and conducting training on them.
  • Following the supervisors orders.
If you have
  • Specialization: completed studies in biotechnology, pharmacy or related fields.
  • Experience in research/development or production of biotechnology products or potential therapeutic molecules.
  • Good knowledge of the principles of good cGMP manufacturing practice.
  • Experience in keeping process documentation in accordance with GMP rules.
  • Very good knowledge of aseptic work techniques, especially in conducting bacterial cultures.
  • The ability to independently solve problems, good organization of work and time.
  • Very good command of spoken and written English; knowledge of MS Office.
  • Flexibility for new tasks, communication skills, ability to work in a team.
  • Experience in the use of stainless steel installations and disposable materials for the production of biotechnological drugs is an additional advantage
  • Experience in working with recombinant proteins will be an advantage
Join our Team!
Why you should work with us
Contact us
career@polpharmabiologics.com


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