Agata Bunia-Howe

Agata Bunia-Howe has extensive work experience in the field of analytical science and pharmaceuticals. Agata has held various roles in different companies, starting with their current position as a Specialist Product Transfer at Akorn Pharmaceuticals since September 2022. In this role, Agata is responsible for project management of analytical method transfers, providing technical support for regulatory submissions, and writing specifications in compliance with FDA regulations.

Prior to their current role, Agata worked as an Associate Scientist at TargImmune Therapeutics AG from October 2021 to September 2022. Agata'sresponsibilities included analytical method development and validation, writing method development and validation reports, and providing technical support in method development.

Before that, Agata was a Laboratory Manager at Ridgeline Discovery from August 2020 to October 2021. Agata'srole involved general laboratory management, monitoring laboratory equipment, collaboration with the formulation team, organizing and maintaining compound libraries, and setting up new laboratories.

Agata also gained experience at MSD as a Scientist, Global Ext. Anal. Management from July 2019 to July 2020. Agata'sresponsibilities included analytical method qualifications and transfers, analysis of drug substances and products, authoring GMP documents, and conducting laboratory investigations.

From 2014 to 2018, Agata worked at Mondelēz International in various roles. As a Scientist II R&D Project Coordinator in Global Analytical Sciences from January 2016 to January 2018, they provided analytical support for manufacturing, developed analytical methods, and led validation and technology transfer projects. In their previous role as a Scientist II in Investigative Analysis from June 2014 to December 2015, Agata managed the Lipids Team and was responsible for planning experiments, writing reports, and maintaining customer relationships.

Agata's earliest work experience was as an Analytical Scientist at TMO Renewables from November 2007 to June 2014. In this role, they arranged laboratory workflow and conducted composition analysis of various feedstocks for bioethanol and biochemical research.

Agata'scareer began at LGC as an Analytical Scientist from January 2004 to November 2007. During their time there, Agata successfully completed analytical projects sponsored by FSA and Government Chemist, analyzed food supplements and raw materials, and conducted method development and validation.

Overall, Agata Bunia-Howe has gained substantial experience in project management, analytical method development and validation, laboratory management, and regulatory compliance throughout their career in the pharmaceutical and analytical science industries.

Agata Bunia-Howe graduated from Lublin University of Life Sciences in 2001 with a Master of Science in Engineering degree. Agata'sfield of study was Food Technology and Nutrition. In addition to their degree, Agata has obtained several certifications throughout their career. In May 2015, they became a Prince2 Registered Practitioner through PEOPLECERT. In April 2019, Agata obtained a certification in Building Self-Confidence from LinkedIn. Most recently, in March 2023, they completed a certification in Method Validation and Transfer with focus on the new ICH Q2(R2) from GLC Europe.