Barbara Cooper

Background

About Barbara Cooper

Experienced and professional Senior Chemist with extensive experience within the Pharmaceutical industry who strives to meet deadlines and targets. Excellent organisational and technical skills, proven abilities as both a project leader and team member in both a QC and development setting. Excels in decision making, root cause analysis and troubleshooting to ensure seamless plant operation and batch release. Works closely with cross functional teams to coordinate and perform analytical testing in accordance with manufacturing timelines and business needs. In my current role I provide support to the departments by providing management and direction to laboratory staff and resources for project activities, overseeing daily operations to monitor quality and project timeliness, and assist in preparation and implementation of company policies, quality systems and training programs. I regularly provide toxicological support to internal and external stakeholders, assist in RCAs and clinical assessments, support IMPD and NDA submissions through analytical analysis and authoring relevant sections. I develop, implement and maintain procedures that comply with appropriate regulatory requirements for analytical method transfer and qualification. I regularly prepare, review and approve study protocols, project status reports, final study reports and other project-related technical documents while coordinating and prioritizing project activities with internal functional groups and support functions which includes supporting new product introduction (method validation, process validation).