Experience

Polpharma Biologics

• Poland
• Biotechnology Research
• 700 & Above Employee

• USP Lead MS&T

  • May 2022 - Present

  Duties:-purchasment of USP lab equipment, preparation of URS-qualification of new equipment-planinng tests and reaserch conducted during technology transfer of monoclonal antibodies manufacturing technology ( scale 10-2000 l) CHO-implementation of scale down models-preparation of documentation: reports, risk assesments and expert assesments for technology transfer- preparation of process validation documentation- Involved in investigations related to deviations- leading the 5 members USP MS&T team Show less

• USP Expert

  • May 2021 - May 2022

  Duties:-purchasment of USP lab equipment, preparation of URS-qualification of new equipment-planinng tests and reaserch conducted during technology transfer of monoclonal antibodies-implementation of scale down models-preparation of documentation: reports, risk assesments and experts assesments for technology transfer

• Senior Drug Substance Specialist (USP)

  • Apr 2020 - Apr 2021

  Duties:-purchasment of USP lab equipment, preparation of URS-qualification of new equipment-planinng tests and reaserch conducted during technology transfer of monoclonal antibodies-implementation of scale down models-preparation of documentation: reports, risk assesments and experts assesments for technology transfer

• Bioprocess Specialist

  • Sep 2019 - Mar 2020

  Duties:-purchasment of USP lab equipment, preparation of URS-qualification of new equipment-planinng tests and reaserch conducted during technology transfer of monoclonal antibodies



BIOTON S.A.

• Poland
• Biotechnology Research
• 100 - 200 Employee

• R&D Specialist

  • Oct 2015 - Aug 2019

  Duties: - planning and conducting cleaning validation reaserch - conducting technology transfer trials to production scale of biosimillars protein (resposibility for fermentation and tangential flow filtration stages) (scale 1l to 10000 l) E.coli - conducting reaserch test in laboratory and semi-technical scale; main skill fermentation - preparation and analysis of documentation from reaserch - preparation registration documentation in CTD format - organization infrastructure and facilite to research test - planning and budget preparation for purchase of new equpiment - contact with suppliers of equipment and raw materials Show less



Polfa Tarchomin S.A.

• Poland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Qualified Specialist

  • Jan 2015 - Sep 2015

  Duties:- preparation of documentation in CTD format for active substances- responding to regulatory quotient from international agencies- cooperation with other departments in new projects- conducting of external GMP audits of raw material suppliers

• Specialist

  • Nov 2013 - Jan 2015

  Duties:- conducting of literature and patent purity for new actie substances and generics products- conducting of laboratory works in new synthesis route of active substance ( light organic synthesis)- preparation of budgets and term plans for new projects - technology transfer of synthesis new active substance from laboratory to semi-technical scale- cooperation with external units in reaserch of new synthesis route of active substance- preparation of production documentation in technology transfer Show less



Galilaeus Oy

• Pharmaceutical Manufacturing

• Junior Production Specialist

  • Jun 2012 - Sep 2013

  Duties: - Supervision of shift work in upstream site (main: fermentation of E. coli, Yeast, Lactobacillus and many other); fermentation scale from 15 liters to 15000 liters. - Laboratory work with downstream stages (centrifugation, filtration, crystallization of active substance) - Work in microbiology laboratory with strain selection - Preparation of production report of batch - Preparation of In Process control analysis - Cost analysis and planning of production projects - Preparation of documentation of batches with GMP requirements Show less

• Intern

  • Sep 2011 - Oct 2011

  Duties: - conducting laboratory trials in microbiology laboratory (preparation of media, strain selection, preparation of working cell banks) - conducting of trials in semi-technical scale of downstream process (filtration and crystallization of active substance) Duties: - conducting laboratory trials in microbiology laboratory (preparation of media, strain selection, preparation of working cell banks) - conducting of trials in semi-technical scale of downstream process (filtration and crystallization of active substance)



Institute of Agricultural and Food Biotechnology

• Poland
• Biotechnology Research
• 1 - 100 Employee

• Intern

  • Aug 2010 - Sep 2010

  Duties: - preparation of analysis beer and malt products - conducting of semi-technical scale of fermentation Duties: - preparation of analysis beer and malt products - conducting of semi-technical scale of fermentation