Town Resident – Brooke Czapkowski
Brooke is currently a Global Submissions Manager in Worldwide Regulatory Operations where she is responsible for the filing of regulatory dossiers in emerging markets.
Previous to this role, she was a Senior Associate in Oncology Operations, PGS, where she was a qualified Drug Product Fill-Finish Operator. In this group she had been involved in manufacturing both Drug Substance and Drug Product for various ADC products for both clinical and commercial markets. In addition to this, she had authored Investigations, Risk Assessments, Forms, SOPs, and MBR sections. Previous to that role, she served as an Associate Scientist at Pfizer in BioTherapeutics Pharmaceutical Sciences. She worked within the Conjugate and Polytide Process Development Group. Her responsibilities included conjugating, purifying, and filtering various antibody drug conjugates(ADCs). She had experience with lysine and cysteine based conjugation chemistries. She also had experience with multivariate analysis through the utilization of DoEs. Additionally, she had been involved in the authoring of various development reports, contributing to BLAs, and verifying data.