Experience

Pharmalucence

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• ILP Supervisor

  • Feb 2017 - Present



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Sr. Manufacturing Associate

  • Oct 2013 - Aug 2016

  • Subject Matter Expert in Filling Operations (ISO 5)Provided training and operator qualifications using RABSExecuted validation protocols and Smoke StudiesWrote and revised manufacturing documents• Cell Culture (e.g. Seeding, Infection and Harvest)• Label Operation• Environmental Monitoring• Quality Systems• Manufacturing support (e.g. autoclaving and staging)• Electronic Batch Records• SAP • Subject Matter Expert in Filling Operations (ISO 5)Provided training and operator qualifications using RABSExecuted validation protocols and Smoke StudiesWrote and revised manufacturing documents• Cell Culture (e.g. Seeding, Infection and Harvest)• Label Operation• Environmental Monitoring• Quality Systems• Manufacturing support (e.g. autoclaving and staging)• Electronic Batch Records• SAP



AMAG Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Production Supervisor

  • Jul 1990 - Oct 2012

  Highlight of expertise include but not limited to the following:Formulation, Aseptic Fill/Finish, Process validation, Improved productivity/efficiency, Manufacturing documentation (Electronic Data Management) and Leadership.Supervised technicians in API and aseptic fill. Facilitated productivity and efficiency by created team work schedules. Increased production capacity from 2 to 2.5 API batches per week.Manufactured bulk and finished products according to cGMP and utilizing SOPs in controlled/aseptic environments. (ISO-7 and ISO-8)Reviewed and executed validation protocols (e.g. cleaning validation/IQP/OP/PQP)Wrote and revised manufacturing documents (SOPs/BPRs)Supervised TFF Ultrafiltration, Filter Change and Tank replacement projects.Worked closely with Engineering, R&D, QA and QC departments.Managed weekly Manufacturing meetings with other departments to ensure production schedules and timelines were met.Performed Employee and Team Development: one-on ones, self-evaluations, quarterly/yearly reviews and team building.