Process Matter Experts Team Manager
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
For our Technical Operations Department we are looking for a Team Manager who will lead the operations and manage activities of the Process Matter Experts Team. In this position you will lead a team responsible for scheduling, preparation, coordination, and execution of technology transfer, production and validation activities reporting to the Director of Production. You will participate in process handover in accordance with cGMP and internal regulations during the introduction of new biotechnology products into commercial production. You will also support commercial manufacturing of biotechnology products in accordance with GMP principles and FDA requirements as process experts.
Your responsibilities
- Leading, coordinating and managing a team of manufacturing process experts
- Participation and monitoring of technology transfer processes and commercial production in accordance with the principles of cGMP and internal regulations
- Compliance of all activities undertaken by the team with the requirements of cGMP, FDA, EMA, ICH
- Problem solving, investigation of deviations, implementation of changes in accordance with cGMP and internal regulations, supporting the production operational team
- Supporting qualifying activities, supervision of qualification documentation in accordance with GMP and internal regulations
- Supervision of process and system documentation, ensuring an appropriate status enabling continuous work in accordance with the requirements of cGMP.
- Preparation and review of process documentation in accordance with GMP rules
- Creating system documentation necessary for the smooth operation of the active substances Production Department in accordance with GMP standards
- Close cooperation with the MSAT and Tech Transfer
- Monitoring the progress of preparation for inspections / external and internal audits
- Planning, preparing and executing technical trials within the scope of process transfer
- Preparation and review of risk assessments and other technical documentation.
If you have
- Higher education in biotechnology, pharmacy, engineering or similar;
- At least 5 years of experience in bioindustry and supervision of manufacturing processes in accordance with cGMP;
- Experience in managing a subordinate team, good organization of own work and subordinates;
- Excellent knowledge of USP and DSP Processes and biotech unit operations;
- Experience with recombinant proteins;
- Experience in technology transfer processes and validation;
- Good knowledge of cGMP and FDA requirements;
- Experience in major health authority (FDA, EMA, etc.) inspections beneficial
- Experience in keeping and reviewing process documentation and project documentation according to GMP requirements;
- Excellent knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production will be additional advantage;
- Fluent English;
- Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks.
- Experience working in multisite cross-functional teams in an international organization.