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Research & Development Department – Product and Process Development Laboratory
The Product and Process Development Laboratory in the Research and Development Department is where most of the new research projects in the company originate. It is here where innovative solutions are developed and implemented to optimize the processes of development of mammalian, insect, and bacterial cell cultures and purification processes of the obtained recombinant proteins. The cell culture team deals with designing and obtaining expression systems and derivation of stable cell lines to produce biological drugs, including biosimilars. The purification team develops and optimizes methods for the purification of protein products. Our analytical teams develop, qualify and validate biological and physicochemical methods in order to monitor the ongoing processes and the quality of the resulting products even at the early stages of development. A broad panel of analytical methods is also used for protein product characterization and biosimilarity studies for biosimilar drug molecules. In the R&D Department, we also work with the characterization of processes carried out in the Manufacturing Department. We can reproduce the manufacturing process at laboratory scale to verify the influence of various factors on the final quality of the product, from cell culture to product purification. We participate in consultations with regulatory bodies EMA and FDA.
Research & Development Department – Medical Section
We are responsible for key activities related to conducting clinical trials. What distinguishes us from similar units is the fact that we are directly involved not only in verifying the workflow at clinical sites, but we also take an active part in the entire process, which includes:
- designing the clinical trial and consulting the strategy with EMA/FDA,
- development of the study protocol,
- clinical trial start-up, supervising and monitoring the work of clinical sites and CROs,
- creating reports and closing the clinical trial,
- preparing the clinical part of the dossier for the registration of a medicinal product with EMA/FDA.
Another distinguishing feature is our experienced team of clinical analysts who focus on developing demanding and unique analytical methods. These methods allow us to characterize key clinical trial parameters such as pharmacokinetics, pharmacodynamics or immunogenicity using innovative analytical techniques and equipment – all in GLP-certified laboratories. Working in our team allows you to develop and learn about all phases of a clinical trial, with actual influence on its design and conduct.
Quality Control Department
Working in the Quality Control Department provides you an opportunity to participate in a variety of projects. We work with modern equipment and a wide panel of various analytical methods, such as high-performance liquid chromatography, flow cytometry, mass spectrometry, capillary electrophoresis or real-time polymerase chain reaction (RT-PCR). We conduct in vitro cell cultures and biological activity tests. The primary tasks of the Quality Control Department include:
- testing the biological and physicochemical properties of proteins produced at Mabion,
- quality verification of all raw materials used in the production process,
- testing the stability of products at all stages of production and determining their shelf life – verifying the microbial purity and/or sterility,
- development of quality documentation.
In addition, our team actively participates in the preparation of data needed for product registration and validation of analytical methods, as well as supports sterile processes such as product filling and simulation of the product filling process.
DIRECTOR, QUALIFIED PERSON:
Dorota Owczarek – Hamrol
In Manufacturing, we combine scientific knowledge with advanced technology and turn it into innovative projects. Our primary focus is to produce sterile biological products through the steps of cell culture, purification, and filling and packaging of the finished product. We have state-of-the-art process equipment and are the first – and so far the only – plant in the world to use “orbital shaking” technology at 2500L scale. Our structure encompasses a wide variety of disciplines, such as:
- production planning,
- manufacturing of recombinant protein sterile products,
- process validation,
- procurement of raw materials for manufacturing, materials for Quality Control and R&D activities,
- investment and qualification of equipment and systems,
- personnel training,
- working in compliance with GMP guidelines,
- logistics in clinical trials and supervision of investigational drug products.
Quality Assurance Department
Our Quality Assurance Department maintains the developed standards at the highest level. It oversees the efficient and proper functioning of the company, which includes:
- optimizing operational procedures,
- defining procedures based on risk management,
- supervision of trainings,
- audits of material suppliers and contract manufacturers,
- internal audits,
- quality reviews of manufactured products,
- supervision of equipment qualification,
- process validation and subsequent verification,
- supervision of the change control system and verification of its effectiveness.
Due to the nature of our activities, we cooperate with all departments and take part in every stage of the drug development process: from early stages to distribution.
Working in the Regulatory Affairs Department provides you the opportunity to interact with Manufacturing, R&D, Quality Control, Quality Assurance departments. We support projects through internal consultations, documentation assessment, and problem solving. We identify risks for projects and find solutions for them. We also provide support to external consultants and, if necessary, make inquiries to Regulators as part of advisory procedures. We support projects by identifying quality requirements at different phases of drug development, as well as selecting the optimal regulatory path. We plan analytical and clinical studies and oversee the development and validation of analytical methods.
Working at Regulatory Department requires high qualifications, which include scientific and technical knowledge, together with awareness of regulatory guidelines, restrictions and requirements. Therefore, we recruit specialists from various areas, mostly through the internal recruitment procedures.
REGULATORY EXPERT, BIOTECHNOLOGY SPECIALIST:
dr Dorota Jaros
REGULATORY EXPERT, BIOTECHNOLOGY SPECIALIST:
Project Management Office
The Project Management Office ensures effective execution of projects and defines standards and guidelines for their implementation. The tasks of the Office are interdisciplinary – during the process they combine the following responsibilities: business, legal and substantive, including among others:
- project implementation and optimization support at every stage,
- priority management based on schedules, including defining roles and responsibilities necessary in each project,
- participation in project methodologies and processes,
- supporting various stakeholder groups,
- distribution of information important in business areas,
- standardization of processes across departments,
- coherence of activities by developing a common language, culture and way of thinking about projects.
The most important role of the Project Management Office is to bring people, processes and tools together in a way which ensures project success. Our daily work is to implement and combine best practices and processes.
dr Anna Czubatka-Bieńkowska
The Maintenance Department is responsible for maintaining the plant’s infrastructure and equipment in proper technical condition for safe operation. We are responsible for the availability of utilities, necessary for the operation of the plant, including clean utilities, manufacturing operations. We supervise the production of WFI water, provide electricity, heat, cold, and technical gases. We take care of an extensive HVAC system to ensure environmental conditions for rooms of different cleanliness classes, according to ISO standards and pharmacopoeial guidelines. There is also a qualification unit within the Maintenance Department. The unit works closely with the technical part of the maintenance department, and with every department within Mabion. It is responsible for maintaining the equipment of all departments in a qualified condition. It also supervises measuring and control equipment to ensure timely calibrations. The Maintenance Department works in compliance with the GMP system.
It is a department that combines competences from different areas of a business organization. Its interdisciplinary nature allows for broad support of many of Mabion’s activities, facilitating the execution of the Company’s projects. Administration Department specialists are responsible for the following issues:
- company information policy (PR/IR),
- hard and soft Human Resources (including employee development management and recruitment),
- EU projects,
- legal services,
- purchasing and procurement,
- management office,
- environmental protection and Integrated Management System,
- occupational health and safety,
The Administration team, with the support of substantive teams, participates in key scientific and business projects of the company, including international ones. It takes care not only of the company’s external image, but also of its internal environment, e.g. by organizing corporate social responsibility events or team building meetings. Working in this multidisciplinary team provides the opportunity to participate in many projects implemented by Mabion and guarantees rapid development of competences.
Our Finance Department combines accounting, financial controlling, treasury and IT functions. In its daily work it provides information about the company’s activities, assets and financial situation, which is necessary, compliant with the law and gives a proper picture of the reality. It cooperates with all departments of the company and external advisors, as well as institutions, to which it periodically and continuously reports. Transparency and the highest standards are confirmed by annual reviews and audits carried out by independent audit firms belonging to the top ranked audit institutions. The Finance Department also ensures that economic events are reflected correctly and in accordance with regulations, which is the basis for analyses performed for current reporting needs and serves as the basis for extrapolations and short- and long-term forecasts. The department also performs a liquidity management function that allows for proper planning and settlement of ongoing projects or transactions taking into account the necessary sources of funding to be obtained.
MEMBER OF THE MANAGEMENT BOARD: