ERIC CHRISTIAN
COLUMBIA,SC
Summary
Proactive Manufacturing Manager with 27 years of Manufacturing and Pharmaceutical supervisory experience in a cGMP environment. Dedicated to leading by example and ensuring quality products through detail-oriented inspections and continuous process improvement. Effective at introducing modern computer and organizational systems for efficient production methods.
Overview
27
27
years of professional experience
Work History
Aseptic Processing Manager, Senior Process Development Engineer
Ritedose Pharmaceuticals
05.2005 - Current
- Overall responsibility for management and oversight of all Commercial and R&D dispensing and compounding of sterile products
- Streamlined manufacturing processes, increased productivity, and reduced costs while continuing to expand rapidly
- Led engineering and operations team responsible for equipment and process improvements
- Reduced operator error by implementing equipment and processes to semi-automate compounding and product transfer
- Increased output and efficiency by designing and implementing new equipment and processes to increase batch size by 100%
- Investigation of process and product deviations and incorporation of effective corrective and preventive actions
- Creation and execution of protocols and studies to establish production parameters
- Authoring technical reports and assisting in preparation of regulatory documents and related regulatory inquiries.
- Successfully managed team of 35 staff, providing assistance and answering questions.
- Adhered to all applicable compliance and regulatory requirements.
- Helped Dispensing and Compounding departments grow in size and effectiveness throughout expansion process.
- Evaluated and assessed employee performance to meet production and data targets.
- Created production schedules to effectively fulfill production plans and meet process goals.
Senior Development Scientist
DSM Pharmaceuticals
07.2004 - 05.2005
- Primary technical expert for project teams and lead/coordinate activities to ensure successful completion of projects including resolution of customer and technical issues
- Process development, process scale-up, and process optimization of sterile dosage forms including development batch manufacture, clinical trial batch manufacture and other related activities leading to product commercialization
- Preparation and execution of development protocols and technical reports and assisting in preparation of regulatory documents and related regulatory inquiries
- Resource contact for customer representatives and DSM Sterile Production, troubleshooting and participation on quality and process deviation issues and investigations, cleaning studies, product compatibility studies, training manual development, lyophilizer troubleshooting, manufacturing record creation.
Development Scientist III
10.2002 - 07.2004
- As lead Pharmaceutical Development Services representative for commercial products, served as liaison and resource contact for customer representatives and DSM Sterile Production, troubleshooting and participation on quality and process deviation issues and investigations, production scale-up and cleaning studies, process optimization, product compatibility studies, training manual development, lyophilizer troubleshooting, manufacturing record creation
- Planning, drafting, and execution of commissioning and qualification documents for new automated aseptic liquid and lyophilized product filling line
- Review and approval of validation packages for new automated aseptic liquid and lyophilized product filling line
- Simultaneously managed several complex projects, meeting all pertinent milestones
Research Scientist
Meridian Medical Technologies Inc
02.2001 - 10.2002
- Project Leader of pilot plant product manufacturing, managed and supervised technical transfers of parenteral dosage forms from research and development to commercial manufacturing
- Responsible for team of eight scientists and technicians
- Direction of product and protein formulation, filtration, and aseptic filling, product compatibility studies and testing, design and execution of product stability studies, production scale-up studies, terminal sterilization cycle development.
Supervisor
Microbiological Services
05.1999 - 02.2001
- Supervision, hiring, training, assessment and development of three microbiologists and five technicians
- Responsible for development and validation of new testing methods, conducting FDA and customer audits, non-conformance investigations, product batch release testing, stability testing, qualification and auditing of vendors
- Development, review, and approval of standard operating procedures, analytical testing methods, and product release specifications
- Sterile Production Action Team chairperson, responsible for investigations, corrective actions, and prevention of microbial contamination in aseptic manufacturing and testing areas
- Conducted training sessions in contamination control for manufacturing personnel
- Proposed and implemented modification of Sterility Test Suite from cleanroom to isolator testing and modified existing laboratory to improve contamination control
- Position reported to President/CEO, and General Manager.
Research Associate
06.1998 - 05.1999
- Research and Development of pilot plant manufacturing of products including: chemical and protein formulation and filling, batch record authoring, product compatibility studies, and stability studies
- Development of standard operating procedures for Research & Development.
Microbiologist I
05.1996 - 06.1998
- Identification of organisms using Vitek 32 automated identification system, microscope, and biochemical testing
- Bacterial endotoxin testing (Gel clot and Turbidimetric/Chromogenic), sterility testing of products, bioburden testing of water and products, container closure testing
- Procedure revision and authoring, validation testing of products including inhibition/enhancement and bacteriostasis/fungistasis testing.
Education
Bachelor of Science - Biology
Fontbonne University
St. Louis, MO05.1996
Skills
- Process Validation
- Key Performance Indicators (KPI)
- Process Improvement Design
- Advanced Manufacturing Process Development
- FDA Regulations
- Cross-Functional Team Collaboration
- New Process Implementation
- Productivity Improvements
- Continuous Improvements
- New Product Development
- Root Cause Analysis
- Project Management
Timeline
Aseptic Processing Manager, Senior Process Development Engineer
Ritedose Pharmaceuticals
05.2005 - Current
Senior Development Scientist
DSM Pharmaceuticals
07.2004 - 05.2005
Development Scientist III
10.2002 - 07.2004
Research Scientist
Meridian Medical Technologies Inc
02.2001 - 10.2002
Supervisor
Microbiological Services
05.1999 - 02.2001
Research Associate
06.1998 - 05.1999
Microbiologist I
05.1996 - 06.1998
Bachelor of Science - Biology
Fontbonne University
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