Expert Details

Expert in Pharmaceutical Processing and Packaging

Expert ID: 735020 California, USA

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Expert has over 20 years of experience in engineering and technical services. He has lead teams of engineers working in development, material qualification process development/ qualification, as well as lifecycle management for both new and existing combination/ non-combination products.

Expert has held positions of principal engineer, manager of technical services, senior principal engineer, project engineer and many more. He has three publications to date. The first deals with active temperature controlled systems. The second deals with identification and classification of nonconformities in molded and tubular glass containers (focusing on pharmaceutical manufacturing), and the third deals with design and testing of cold chain packaging, specifically for pharmaceutical products.

Education

Year Degree Subject Institution
Year: 2006 Degree: Master of Science Subject: Packaging Institution: Michigan State University, East Lansing, Michigan
Year: 2003 Degree: Certificate Subject: Project Management and Principals Institution: University of California Santa Cruz
Year: 1999 Degree: Bachelor of Science Subject: Nutrition and Food Science with a Concentration in Packaging Technology Institution: San Jose State University, San Jose, CA

Work History

Years Employer Title Department Responsibilities
Years: 2011 to Present Employer: Undisclosed Title: Principal Engineer Department: Device Product Technologies Responsibilities: - Lead a team of eight engineers for development, material qualification, and process development/qualification and lifecycle management for new and existing combination/non-combination products.
- Technical lead for design/develop and characterize of novel packaging process utilizing an ultra-cold (-80°C) environment
- Own department portfolio management process (Budget, resource forecasting and modeling, project prioritization, etc.)
- Building a transformation road map to increase the maturity level of the organization. Lead packaging design workshop, value stream mapping, establish standard work for package testing, established specification templates, alignment of packaging development process between multiple Amgen sites, establishment of project management system.
- Technical lead for tech transfer of Amgen product to CMO in Japan, Russia and Canada.
- Reduced incoming inspection NC’s at sites related to specification by establishing specification templates, alignment of inspection criteria, elimination of redundant inspections, alignment of supplier defect criteria and identification of critical to quality defects applicable to the manufacturing process.
- Core team member of Device Warning Letter to resolve qualification gaps and closure of warning letter.
- Championed innovation by designing an innovative vial sleeve solution for Imlygic labeling which allows for product to be labeled after freezing. Provides supply chain flexibility and reduction of scrap.
Years: 2007 to 2011 Employer: Baxter BioScience Title: Manager Department: Technical Services Responsibilities: -Managed and developed staff of Engineers to perform on floor support for aseptic processing, lyophilization, packaging, labeling and cold chain distribution.
- Member of Van Nuys warehouse team to add capabilities for US Distribution of Albumin and AHF-M. Established TSA certified warehouse, developed and qualified cold chain packaging, performed lane validation and established cold chain supply chain.
- Implement lean manufacturing tools for standard work, 5S and statistical process controls.
- Investigated supplier quality issues with primary packaging, distribution materials and materials used for aseptic processing.
- Perform department yearly budget, quarterly FTE forecast and reported dept. metrics.
- Member of GMP excellence team to improve training and feedback for GMP improvements which resulted in a 10% reduction of deviations/events.
-Utilized DMAIC problem solving tools to reduce finished product reject rate for Japanese market by 35%.
Years: 2006 to 2007 Employer: Baxter BioScience Title: Sr. Principal Engineer Department: Technical Services Responsibilities: -Established team of engineers to provide support for packaging/labeling and aseptic processing operations
-Technical Project Leader for development and implementation of brand protection for BioScience Division
- Lead investigation for Class 3 NC’s for glass breakage, particles, sterility and media fill failures.
- Designed and implemented packaging for Japanese market. Implemented heightened visual inspection criteria for particles, packaging materials and glass bottle defects.
- Established training program for glass bottle inspection and established defect limits and defect library
-Develop primary containers for small and large molecule products. Ensure container closure integrity.
-Project manager for implementation, validation and procurement of capital manufacturing equipment (packaging and filling)
-Core team member of Shingo Award Team for LA Plant. Plant received Bronze Award.
Years: 2005 to 2006 Employer: Baxter BioScience Title: Principal Engineer Department: Technical Services Responsibilities: -Established cold chain packaging and distribution process for BioScience Division. Harmonized cold chain packaging used across division.
-Performed temperature mapping and validation of Baxter trucks for cold chain distribution.
-Managed temporary and contingent staff
-Technical lead for harmonization of packaging validation procedures, specifications and design.
-Established primary container defect acceptance criteria with suppliers and customers to increase final container yield by 10%.
-Technical leader for implementation of vial label and carton 2D bar coding project
-Track and trend manufacturing business and technical yields. Initiated yield improvement projects based on data analysis.
Years: 2004 to 2005 Employer: Federal Express Title: Project Engineer Department: Federal Express Responsibilities: -Lead packaging development projects related to pharmaceutical, diagnostic and medical device customers.
-Provided customers with cold chain distribution and packaging solutions for high value products.
-Monitored customer cold chain shipments to highlight hazards seen within the distribution environment to the customer.
-Worked with FedEx custom critical to establish shipping process for cold chain products.
-Perform station and hub audits to ensure compliance with FedEx Quality Systems.
-Performed contract negotiations, freight planning/analysis and business development activities.
-Trained on handling and packaging of dangerous goods per IATA.
-Work with stations and ramps (airport) to improve processing efficiency using statistical process control and periodic auditing.
-Established station metrics for efficiency, on-time delivery and damage claims.
-Develop and provide training to operations personnel for proper package handling and acceptance.
Years: 1999 to 2004 Employer: Nektar Therapeutics Title: Packaging Engineer Department: Responsibilities: -Technical Leader for design, implementation and validation of new commercial secondary device packaging equipment at contract manufacturer facilities located in England and Arizona
-Technical leader for device clinical packaging and process development.
- Lead investigations for ERs and CAPAs.
-Established incoming quality and receiving measurement tools and methods for contract manufacturers.
- Maintain and develop bills of materials, component specifications and incoming material inspection methods.
-Develop testing/validation protocols per ASTM-D4169and ISO 11607.
-Develop and validate cold chain packaging for domestic and international distribution.
-Develop functional requirements specifications for commercial packaging equipment, execute and develop validation protocols (IQ, OQ, PQ, and PV).
-Contributed to the preparation of Common Technical Document (CTD) to support NDA.
-Lead technology transfer of components and in process inspection procedures to contract manufacturers.

Career Accomplishments

Publications and Patents Summary
Publications: 3
Patents: 1

Fields of Expertise

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