Experience

Mabion S.A.

• Poland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Biochemistry Specialist, Project Team Leader

  • Dec 2020 - Present

• Junior Biochemistry Specialist, Project Team Leader

  • Sep 2020 - Dec 2020

• Junior Biochemistry Specialist, Project Leader

  • Dec 2019 - Sep 2020

  - HPLC analytical methods development for biosmilars characterization according to EMA and FDA regulations- Planning and coordination of biosimilarity studies including freezing stability and accelerated stability (freeze-thaw) studies- Reference drug purchase supervision- Participation in eCTD documentation preparation

• Biochemist

  • Nov 2017 - Dec 2019

  HPLC analytical methods development: - HILIC method optimization for biosimilar candidate glycosylation profile assessment and comparison - Optimization and qualification of HPLC-method dedicated to amino acid composition evaluation in culture supplements - Utilization of DoE approach and application of EMA and FDA regulations during methods developmentParticipation in interdisciplinary projects: - Protein-A chromatography purification of monoclonal antibodies within process space determination and process validation activities (AKTA Explorer/Avant) - Impurities isolation and characterization based on semi-preparative chromatography techniques (Schimadzu Nexera) - Analysis execution for aggregates, charge variants and glycosylation profile assessment within process space determination and similarity/comparability studies (Agilent Infinity HPLC, Thermo Fisher Vanquish UHPLC) Show less



Unesp

• Brazil
• Higher Education
• 700 & Above Employee

• Internship Trainee

  • Aug 2017 - Oct 2017

  Transgenerative effects of metabolic disorders - in vivo studies Transgenerative effects of metabolic disorders - in vivo studies