Process Transfer and Validation Manager

Location: Duchnice (Warsaw) - Poland

Join our team as the Head of the Process Transfer and Validation Team, where you'll play a pivotal role in guiding the expertise in drug substance manufacturing process transfer and biotechnology process validation. This includes overseeing cleaning validation, transport validation, continuous process verification, and related activities.

Your leadership will be instrumental in supervising the introduction of new products up to the stage of launching commercial production. You'll be actively involved in conducting and supporting technology transfers and validation processes within the Polpharma Biologics Group, ensuring efficient and timely registration of new processes.

Your responsibilities include, but are not limited to:

Leadership and People Management:

•    Managing a Process Transfer and Validation Team by organizing the work of the subordinate team in order to make the most effective use of working time and task execution, monitoring the status of ordered tasks;
•    Stimulating the development of subordinate employees;
•    Recruiting, developing and retaining people with unique abilities;

•    Create a culture of responsibility and innovation in the department;

Technical:

•    Leading and supervising the introduction of new products to the stage of launching commercial production;

•    Supervision and development of technology transfer strategy, including pre-validation and validation activities, including the strategy for supportive studies;
•    Supervision and monitored activities between all departments involved in individual activities of technology transfer and drug substance manufacturing  process validation, cleaning validation and transport validation;
•    Initiation of the monitoring and continuous process verification phase and compilation of the first APQR;
•    Contribution to the overall strategy and plans of TT projects scope of which includes the process validation phase, including the creation of schedules and budgets;
•    Supervision and/or development of  OPV/CPV processes and related documents;

•    Coordinating the preparations for the production campaign (as part of the technology transfer, validation of the active substance manufacturing process);

•    Contribute to the optimization of technology transfer and validation processes;

If you have:

•    Min. 8 years of professional experience in the biotechnology industry in the production area, technology transfer,  process validation, cleaning validation, and transport validation;

•    Several years of experience in managing a team

•    Experience in working with recombinant proteins on a production scale;
•    Practical knowledge of technology transfers;
•    Practical knowledge of process validation, cleaning validation and transport validation;
•    Excellent knowledge of GMP, EMA, and FDA requirements and current  guidelines  for technology transfer, process validation in the biotechnological industry;

•    Very good speaking and writing English skills;

 

What we offer:

•  Relocation package;
•  Competitive salary;

•  Company car
•  Yearly bonus;
•  Occasional bonus;
•  Lunch card;
•  Private healthcare;
•  Life insurance;
•  English lessons platform; 
•  Office activities: mindfulness sessions, joga lessons, workshops, and more...