Joseph Revello Email & Phone Number

Meriden, CT, US

* Successfully led technology transfer and scale-up of purification processes for three monoclonal antibodies from process development into GMP manufacturing on schedule, including equipment qualification and completion of Engineering batches.* Supervised manufacturing of more than 100 GMP drug substance batches with a release rate of >97% to meet drug.

* Planned, executed and managed all aspects of downstream processing in compliance with cGMPs.* Authored and reviewed cGMP documents including standard operating procedures, manufacturing batch records, change control documents, and deviation reports for the downstream processing area.* Hired, trained and developed downstream processing staff and managed.

* Supervised manufacturing of >100 GMP drug substance batches to meet market drug supply requirements.* Managed group of exempt employees responsible for the generation and accuracy of required cGMP documentation (batch records, standard operating procedures, investigation reports, validation protocols and summary reports, modification/change requests.

* Supervised In-Process Control Laboratories and performed in-process testing to support manufacturing of bulk biologics.* Provided required cGMP documentation (batch records, standard operating procedures, investigation reports, validation protocols and summary reports, modification/change requests, etc.) for manufacturing processes.* Maintained inventory.

Trained in general laboratory techniques, including solution preparation, filtration, centrifugation, and distillation. Maintained records of experimental data and samples for analysis. Developed purification processes for several proteins. Operated column chromatography, ultrafiltration/diafiltration, and centrifugation equipment. Performed various.