USP Cell Culture Plant Manager
Warszawa
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
Perform project tasks related to the expansion and development of new production lines. Supervise the scheduling and execution of activities related to the acceptance and qualification of production equipment. Implementation of production and research and development plans with the optimal use of the available resources (production, human). Manufacture of biotechnology products in accordance with GMP principles and FDA requirements to obtain a product of specified quality in the specification.
Responsibilities
- Ensure implementation of project plans.
- Supervision of the implementation of the equipment design, technical acceptance and qualification schedule;
- Supervision of the consumption of raw materials, auxiliary materials and reagents and energy media in relation to production plans;
- Supervision of the manufacturing process of biotechnology product according to GMP requirements, technological documentation and other internal requirements;
- Verification design, production and qualification documentation according GMP rules and internal;
- Participation in technology transfer, process validation in cooperation with other departments;
- Actual delivering supervisor or proper people reports and all necessary documentation to process evaluation;
- Preparation of the Department for internal and external audits. Participation in all audits in own area;
- Close cooperation with the Production Department and the Quality Department;
- Cooperation with all groups from site and Polpharma Biologics;
- Performing activities ordered by the supervisor;
- Checking and approving production documentation (eg. batch records) and validation;
- Determining training needs and delegating shift workers for trainings;
- Conducting and participating in trainings;
- Participation in creating the company's budget;
- Organizing the work of the subordinate team in order to make the most effective use of work time and task performance
If you have
- University degree in biotechnology, chemistry, pharmacy or related;
- At least 3 years' experience in similar position within the biotech or pharmaceutical company;
- Good knowledge of cGMP and FDA requirements
- Experience in keeping and reviewing process documentation and project documentation according to GMP requirements;
- Experience in using aseptic techniques and Single Use Technology used in biopharmaceutical production will be additional advantage;
- Experience in conducting investigations and documenting deviations, CAPA and change control;
- Very good speaking and writing English skills;
- Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required;
- Skills: managing people, good work organization, independence, communication and interpersonal skills;
- Knowledge of performing monoclonal antibody production process (DS) in production scale according to GMP rules;
- Experience in qualification of equipment, installation and systems.
We offer
- Company car;
- Competitive salary;
- Private healthcare;
- Life insurance;
- Pension plan above national standards;
- Relocation package;
- Additional free day;
- and more...
Perform project tasks related to the expansion and development of new production lines. Supervise the scheduling and execution of activities related to the acceptance and qualification of production equipment. Implementation of production and research and development plans with the optimal use of the available resources (production, human). Manufacture of biotechnology products in accordance with GMP principles and FDA requirements to obtain a product of specified quality in the specification.