Karolina Lesniewska, Phd Email & Phone Number

Poland

I lead a dynamic team of process data leaders, experts, and specialists, ensuring that our work aligns seamlessly with internal standards and procedures. My role revolves around orchestrating and spearheading activities focused on data analysis within the realm of monoclonal antibodies production.Enhancing Data Acquisitions: Leading an initiative to fortify data acquisition processes, elevating the robustness of data management to ensure compliance. Devised and implemented a more operationally lean system for efficient data handling.Taking ownership of establishing a comprehensive ongoing process verification plan. Ensuring the timely release of associated reports, featuring in-depth process analyses and actionable recommendations, contributing significantly to maintaining a validated and controlled process.Holding a pivotal role in cleaning validation and ongoing cleaning verification, safeguarding the continuous validation and control of the production process. Regulatory Audits Expertise: Actively participated in regulatory audits, serving as a Subject Matter Expert (SME) to ensure compliance and adherence to industry standards.Providing support in deviation investigations, change control assessments, and the implementation of Corrective and Preventive Actions (CAPA). Leveraged extensive knowledge to troubleshoot routine process issues and support Production.Supporting the organization in achieving critical milestones, aligning with the company's vision and goals.

Gdańsk, Pomorskie, Poland

Comprehensive data analysis across manufacturing processes for process control, trending, ongoing process verifications, and continuous cleaning verifications. My responsibilities extended to reviewing and analyzing data associated with Good Manufacturing Practice (GMP) production and process validation.Cleaning Validation Leadership: leading the cleaning validation of stainless steel manufacturing installations. Instrumental in designing studies that shape the development of the cleaning process, cleaning validation documentation, including master plans, protocols, Standard Operating Procedures (SOPs), risk analyses, and reports. Acted as the go-to troubleshooter and served as the first point of contact for all aspects of cleaning validation. Established and managed an ongoing cleaning verification plan, ensuring the sustained validation and optimal performance of the cleaning process over time.Quality Record Management: Initiated and supported quality records, including change controls, deviations, and Corrective and Preventive Actions (CAPAs), contributing to a robust quality management system.Regulatory Audits Expertise: Actively participated in regulatory audits, serving as a Subject Matter Expert (SME) to ensure compliance and adherence to industry standards.

Gdańsk, Woj. Pomorskie, Polska

Glasgow, Glasgow City, Wielka Brytania

- Responsibility of overall conduct of client-driven GMP productions- Generating Technical Specifications, production documentation and performing all up front processes required to prepare for cleanroom productions- Providing hands-on support, training, guidance and mentorship to laboratory-based personnel, whilst ensuring GMP productions and supporting studies are completed on time and to the appropriate scientific and regulatory standards- Raising and progressing deviations records- Designing and constructing work pertaining to more complex production processes and investigations- Liaising with Commercial, Development Services, Programme Management and other Laboratory Operations to provide technical support for ongoing and upcoming projects- Participating in external and internal client conference calls- Implementing improvements to processes and procedures to improve efficiency and reduce waste

Slough, United Kingdom

- Development, evaluation, characterisation and validation of protein purification processes for monoclonal antibodies and other recombinant proteins. Support the transfer of these processes to pilot and GMP scale.- Design of Experiment (DoE), planning the experimental set-up and analysing the data using Design Expert software - Experience of GAP analysis methodologies (participating in FMEA and Cause and Effect Analysis)- Collate, analyse and evaluate data to produce good quality process information- Prepare and deliver high quality presentations, protocols and reports- Operating ÄKTA Purifier chromatography system for lab-scale protein purification- Performing Tangential Flow Filtration using KrosFlo Research IIi, Cogent µScale TFF system and Quattro for diafiltration and concentration of solutions. - Data analysis using UNICORN5.31 software.- Participate in customer telecons- Trainer of basic laboratory techniques for new employees to ensure SOPs are performed to a high standard- Risk assessor

Edinburgh, United Kingdom

- Generating tools for investigating cohesion establishment. Preparing antigen for animal immunisation, testing animal bleeds for immunogenicity. - Screening for novel interactors of Scc2 and Scc4.

Data Analyst

Python programming: automation of report generation using Python, scrapping data from external services and websites as well as database.

Doctor Of Philosophy (Phd), Cell/Cellular And Molecular Biology

PhD thesis title: New Tools Reveal Interaction Determinants and Post-mitotic Function of Crucial Microtubule Regulators. Supervisor: Prof..

Bsc (Honours), Biological Sciences (Biotechnology)

Honours thesis title: Purifying Factor I-like Module from Inclusion Bodies for Structure Analysis. Supervised by Dr. Janice Bramham.