Joseph Ellis
President and Principal Scientist at SterileEdge Consulting.
- Role
- President & Principal Scientist at Sterileedge Consulting
- Location
- Phoenix, AZ, US
- LinkedIn followers
- 500 followers
About Joseph Ellis
Experienced in all facets of aseptic manufacturing, including compounding, prep, fill, lyophilization, inspection, and packaging. Also experienced in lyophilization cycle development, optimization, and process qualification. Other responsibilities included writing protocols, summary reports, and SOP\'s as well as improving processes and interfacing with regulatory agencies. Also experienced in safety and environmental regulatory compliance, training, and program administration. Certified Lean Leader and 6-Sigma Green belt.Lead investigator for multiple complex manufacturing investigations and preforming successful root cause analyses.Specialties: Lyophilization, Aseptic Processing, Aseptic Filtration, and Process Development/Process Improvement. Also, RCRA compliance, respiratory protection training, and safety auditing.
Experience
President & Principal Scientist
Feb 2025 — Present · Phoenix, AZ, US
Consulting on manufacturing process improvement and optimization with particular expertise in aseptic pharmaceutical manufacturing. • Developing lyophilization cycles and conducting aseptic process assessments to enhance efficiency.• Performing process deviation investigations that correctly identify the deviation, determine the true root cause, establish product impact, initiate corrective and preventative actions that directly address the root cause, and perform effectiveness checks that accurately verify that the identified root cause was mitigated. • Implementing 6S methodologies and continuous improvement initiatives to streamline operations, eliminate the potential for errors, and reduce manufacturing costs.• Conducting data-driven analyses to identify and resolve deviations, ensuring compliance and quality.
Education
Emporia State University
Biology
Shawnee Mission South High School
High School, College Prep
Skills
- Aseptic Processing
- Sterilization
- Cgmp
- Change Control
- Rcra Compliance
- Lyophilization
- Safety Auditing
- Compliance
- Biotechnology
- Gmp
- 21 Cfr Part 11
- Pharmaceuticals
- Aseptic Technique
- Pharmaceutical Industry
- Sop
- Fda
- Validation
- Process Validation
- V&V
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