Sonja Nicoll

Experience

• 

  University of Konstanz

  Jul 2009 - Dec 2009

  Scientific Researcher

  Protein characterisation (Enzymology)

• 

  The Ohio State University

  Jan 2010 - Dec 2010

  Postdoctoral Researcher

  - Setting up crystallisation capabilities in the lab.- Protein characterisation (enzymology) on several DNA polymerases.- Radiation safety officer for the lab

• 

  Sandoz

  Apr 2011 - Jul 2017

  - Project responsible for drug product development of a biosimilar: Process and formulation development including stability studies (short and long term studies, stress stability studies); compatibility studies; support clinical trial applications- Process transfers (international) including scale-up: Monitoring of production on site; preparation of process-relevant documents like risk assessments, manufacturing and sampling instructions as well as review of batch records- Reference person for microbial aspects during drug product development (includes growth promotion tests, preservative efficacy tests, and definition of microbial hold times; microbial container closure test including method validation; confirmation of suitability of endotoxin, bioburden and sterility test methods)- Building manager Show less - Project responsible for drug product development of a biosimilar: Process and formulation development including stability studies (short and long term studies, stress stability studies)- Process transfers (international): Monitoring of production on site; preparation of process-relevant documents like risk assessments, manufacturing and sampling instructions as well as review of batch records- SOP-responsible for the department pharmaceutical development: adaptation of the distribution system to a grown department with de-localized groups; later centralisation of the system and further adaptation to a bigger group after the department moved to a new localisation- Writing of new SOPs- Building manager Show less

  • Teamleiter

    Mar 2016 - Jul 2017

  • Scientist

    Nov 2013 - Jul 2017

  • Laboratory Scientist

    Apr 2011 - Oct 2013
• 

  Horizon

  Aug 2017 - Oct 2023

  - Product and process development of biologics- Tech transfers from lab scale to large scale- Preparation of Drug Product dossier sections (IND/IMPD, BLA)- Support for change controls, CAPAs, deviations- Mid to Late Phase development of biological Drug Products - Product and process development of biologics- Tech transfers from lab scale to large scale- Preparation of Drug Product dossier sections (Ind/IMPD, BLA)- Support for change controls, CAPAs, deviations

  • Senior Direktor

    Jul 2022 - Oct 2023

  • Director

    Jan 2020 - Jul 2022

  • Associate Director

    Aug 2017 - Dec 2019
• 

  Amgen

  Oct 2023 - now

  Senior Direktor