Javier Sanchez Estrada

Quality Standards Professional with supervisory and 20 years of experience in the Pharmaceutical Industry. Hands-on experience in Raw Materials, Change Control, and Finished Product. Knowledgeable in Change Control, Quality Standard, and MFG process.

Skilled in inspection audits, cGMP document revision, and quality agreements. Responsible, dynamic, and enthusiastic with proven leadership skills. Able to work on multiple tasks in a high-pressure environment with minimal supervision.

Excellent interpersonal and communication skills. Computer literate (TrackWise, LIMS, Werum, Maximo, and SAP systems). Basic knowledge of the English languagenufactura

MFG-Associated (AML-7) – Neupogen, Neulasta, N-Plate Products at Amgen Manufacturing Limited (2008 – Present)

• Buffer preparation (Formulation and Filling)
• Column process: Equilibration and process monitoring with minimal supervision
• Ensured process control and maintained operations with minimal supervision
• UF/DF process
• IB Recovery Process

MFG-Associated (AML-6) – Aranesp, Prolia, and Repatha Products at Amgen Manufacturing Limited (2008 – Present)

• Buffer preparation (Downstream)
• Media preparation (Upstream)
• Component preparation
• Washer and Autoclave operations
• Fully qualified in all processes within the area
• Cross-trained across multiple operational areas
• Provided training to new hire personnel
• Supported Repatha manufacturing process

Production Support at Eli Lilly (2008 – 2011)

• Verified processes to ensure compliance with SOPs
• Supported ticket simplification processes
• Assisted in investigations and deviation events
• Participated in manufacturing processes and supported deviation-related activities

Change Control Coordinator at GlaxoSmithKline (2006 – 2007)

• Responsible for updating the Nova System
• Coordinated weekly panel meetings
• Performed supervisory tasks as needed
• Generated and reported weekly Change Control metrics to senior management
• Conducted monthly safety inspections and reported findings
• Collaborated with Validation Team to support process improvements

Laboratory Analyst at GlaxoSmithKline (2004 – 2006)

• Coordinated raw material laboratory activities
• Performed routine laboratory tests following specifications and procedures
• Revised procedures and recommended improvements
• Assisted in scheduling and reporting duties
• Supported laboratory investigations

Laboratory Technician at Ceph International (2003 – 2004)

• Performed routine raw material laboratory tests according to established procedures

Bachelor's Degree in Chemistry – Ana G. Mendez University, Cupey Campus