Stephen Macmichael Email & Phone Number

Philadelphia, PA, US

Supported TAVT-119, an amlodipine besylate gel in development for pain associated with anal fissure, and TAVT-45, a novel oral suspension of abiraterone acetate.- Oversaw the Quality Assurance documentation management systems of SOLABS and Microsoft Office for the entire company- Reviewed protocols, analytical methods, and specification documents used in.

Florham Park, NJ, US

Supported CYNK-101 and CYNK-001 for treating solid tumors, and Biovance and Interfyl for biomaterial wound healing.- Managed physical and digital databases for patient files, training records, and clinical processing runs- Became very experienced with document control systems Veeva and SharePoint, including producing training reports, updating and.

US

Supported Eagle’s line of products including Bendeka for lymphocyte leuchemia, Ryanodex for malignant hyperthermia, Pemfexy for small cell lung cancer, and Fulvestrant for treating breast cancer.- Designed and implemented a data warehouse for Eagle's new drug development diluent program- Utilized the company SharePoint sites to organize and identify data.

US

- Participated in validation of the electronic documentation system by executing test scripts and reporting results- Updated Quality Assurance forms to work electronically by making them digitally fillable- Created product complaint and change control reports in their Quality Management system software (i.e. SOLABs)- Participated in laboratory tours of.

US

- Created automated reports for product quality complaints, change controls, and training for Quality Assurance within their electronic document management system- Filed and organize manufacturing batch records and other Quality Assurance related documents, and- Trained on cGMP practices, FDA CFRs, and internal Eagle policies and procedures