Polfa Tarchomin S.A.

Becoming a Project Manager for the Center for the Production and Development of Oncological Drugs

I'm a self-employed civil engineer; I was not an employee of TZF Polfa S.A. I joined as a result of later recruitment. The company started the process of implementing the project using its own resources, but at some point, due to unsatisfactory results, it was found that it would be necessary to possess additional competencies from the outside, which task was assigned to the company's HR department and cooperated head-hunting agencies. I would like to make a point out that this investor awareness should be everywhere - it is the basis of project management from the level of program management, i.e. C-level of the organization, the awareness of the need to acquire competencies from the outside when we do not have them in the organization.

The Most Difficult Thing at the beginning of this project

The hardest part was probably building trust in me. Convincing the management board of the company that I am able to achieve the business goals of this project until the end. I joined the project in a really hard and groundbreaking moment. Now, it's easy to talk about it, but it was a hard time, full of effort and building mutual trust in small steps and creating new implementation plans because the previous ones were ineffective for many reasons. The company's expectations regarding the implementation of the new plans were also huge - there was a belief that I would make up for the delays and complete the process in full compliance with cGMP standards. As you can guess - it is hard to make up for months of delays in the horizon of 2-3 years; it is practically impossible. Now, a year after we have our General Contractor who implements the technological scope of the building, I can see how much has been done in these two years since I started working on this project and how great is the achievement of the entire team that implements this project.

Most Helpful in Managing the Project

Certainly, my experience, which I gained while implementing large and complex projects, such as the subway project in Warsaw or the multimodal Łódź Fabryczna underground railway station; I also think that working for consulting companies - as a substitute investor was extremely helpful for me in terms of understanding the needs and requirements of Investors. Recently, I also worked as a project manager in a small general contracting company where I was basically both project manager and construction manager in one person, which also developed the so-called multitasking and managerial skills. The whole spectrum of my experience, from the purchase of investment land and the due diligence process preceding it through negotiations with project stakeholders to the implementation phase, has certainly helped here; unfortunately, if you have never seen the scale of a project worth hundreds of millions and its organization, there is nothing like it there is no way to build and duplicate good solutions and avoid a series of mistakes, which are also inextricably linked with such projects - I was lucky enough to work on large projects and smaller ones too, so I am familiar with a project from the so-called ‘helicopter view’, but also sometimes I can go into detail in the task and perform micromanagement.

"Technologically, we use the latest solutions - isolator technologies for aseptic production, single-use technology for API, rcp ports, these technologies are designed to ensure the safety of operators and products, but also the environment - BIBO, HEPA filters, and separate devices for decontamination of wastewater"

Biggest Challenge for This Project and for You as Its Leader

It is interesting that these challenges are often divergent. It is similar in my case because the project is currently in the most difficult coordination phase - we are starting assembly on all work fronts provided for in the documentation; there is also a lot of work to do to coordinate technology suppliers because we have several dozen of them. We have also started the assembly of pharmaceutical technologies. It seems to me that if we conduct this coordination properly, the project has a chance to reach the planned end with our cooperation. From a broader perspective, it seems to me that nothing worse than the war in Ukraine and the progressing inflation should not affect this investment, although the economic war between China and the so-called Western world can have a big impact on the investment market and sooner than we think, just look at the exchange rate of the dollar to the euro and PLN and their mutual relations.

Personally, I look a bit further, so the challenge for me is to give the user a fully functional facility that meets their requirements, get cGMP certification and start production. I would also like to leave some order and engineering thought in the company, and for this purpose, I am currently focusing heavily on reorganizing the media supply of the entire plant; this is a plan for the coming years, and I want to follow the latest trends in engineering and try to ensure the company's competitiveness in terms of media costs as much as possible - hence the case study on the use of hydrogen generation or kinetic power plants.

Most Difficult Engineering Challenges Faced in the Project

The period of implementation of reinforced concrete works was difficult in terms of engineering. Together with our contractor, we faced the need to build a really complicated excavation drainage system, which had to pump huge amounts of water. Tarchomin is a difficult area when it comes to underground structures, and then we found out about it. Fortunately, the contractor coped without major problems and professionally sealing the underground part, which resulted in the fact that at a fairly high pressure (approx. 5 m water column), we did not record any leaks in the underground part of the facility. Another engineering challenge that we are constantly processing is certainly multi-discipline coordination. It is a really big challenge, and we are currently finishing it, but it costs a lot of effort on the part of designers, contractors, subcontractors, and suppliers - all participants in the process. I think that was actually the hardest thing about this project. On the other hand, I would put the master plan in the same place, which is constantly being developed and supplemented; it is our daily guide both in terms of impact assessment and monitoring of the entire investment. And for that, many thanks to the Planners.

Impact of This on Tzf Polfa s.a. From Pharmaceutical Manufacturing Point of View

It will certainly increase production capacity many times, which will probably translate into revenues in the near future, but we know that the competition is not sleeping; there is no need to kid yourself. Technologies in pharmacy are changing very quickly, and it is difficult to have the latest solutions and be on a TOP during all the time. Our factory will provide additional production capacity in the form of 20 million vials per year from the COMBO line in various formats and forms and 6 million PFSs from the ONCO line. Technologically, we use the latest solutions - isolator technologies for aseptic production, single-use technology for API, and rcp ports, these technologies are designed to ensure the safety of operators and products, but also the environment - BIBO, HEPA filters, and separate devices for decontamination of wastewater. We wanted the project to be completely safe for the environment; it was one of the 'must haves', and since we will be using substances up to and including OEB 5 in production, we had to perform various types of additional analyses - e.g. HAZOP and SIA analysis and select solutions that ensure this safety needs. This facility should become a pattern for the next ones inside TZF Polfa S.A.. Therefore, we plan to obtain UE cGMP, FDA, UAE cGMP and EA cGMP in the next years after launching.