Munib Marwan يوري

Senior Manufacturing Associate I (January 2012 to Present)
Acted as cleanroom Leader responsible for leading and managing a team of 12 operators in a fast-paced quality oriented cell culture production environment.
Media fill participation and maintaining media fill qualification status.
* Led and coordinated annual process validation events with minimal supervision from management.
* Trained new employees in final product packaging and shipping.
* Represented Manufacturing group in cross-functional teams and projects focused on resolving GMP-related problems, non-conformance events etc.
* Act as Subject Matter Expert; mentoring and training new associates in clean room behavior, aseptic process techniques GMP documentation, quality systems, and safety protocols.

DENDREON CORPORATION, Morris Plains, NJ September 2009 to Present

Manufacturing Associate II (July 2010 to January 2012)
Performed principal investigations and executed non-conformance management initiatives.
* Documented deviation investigation reports as required per initiated exception reports as assigned by Quality Assurance.
* Assisted Quality Assurance group in implementing controls corrective actions and preventive actions.
* Ensured the adherence of company and regulatory protocols (i.e. SOP's, cGMP, GLP, PMO, etc.
* Chosen to work on projects with supervisors and managers (Buffy Coat Project, Goggles Project, and Incubator Study)

Manufacturing Associate I (September 2009 to July 2010)
Acted as cell culture processing associate. Performed over 50 aseptic manufacturing of blood derived therapeutics.
* Aseptic gowning certified with over 1000 hours experience in class 100/ grade "A" aseptic environment.
* Performed operation and verification in clean environment using oracle ERP system.
* Reviewed batch records in electronic and paper systems.
* Prepared and assembled kits for sterile operation such as training, validation, etc.
* Actively maintained proficiency in applying aseptic process techniques and gowning certification.
Telephone: (551) 206-0009 Email: