Michael Denzer Email & Phone Number
VP Client Relations @ EdgeOne Medical
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Michael Denzer Location
- New York, NY, US
Michael Denzer Work
- 2025 -now VP Client Relations @
- 2023 -2025 Head - Device and Packaging Engineering, Biosimilars @
- 2019 -2023 Vice President - Client Success @
- 2017 -2019 Sr. Director - Biologics Devices and Combination Product Development @
- 2016 -2017 Head - Device External Operations @
- 2015 -2016 Director - Commercial Devices and Combination Products @
- 2016 -2017 Mentor -Robotics Team 3637, "The Daleks" @
- 2011 -2015 Director - Device Development and Technology @
- 2007 -2011 Sr. Manager - Engineering - Packaging and Device Development @
- 2004 -2007 Principal Engineer - Packaging and Equipment Development @
- 1995 -2004 Engineer - Packaging and Assembly Equipment Development @
Michael Denzer Education
- New Jersey Institute of Technology
Bachelor of Science (BS) (Pi Tau Sigma - International Mechanical Engineering Honor Society, ASME - American Society of Mechanical Engineers - Past Pres & V Pres - NJIT student chapter)
1995-1997
Michael Denzer Skills
- Combination Products
- Drug Delivery Systems
- Parenteral
- Packaging Engineering
- Medical Devices
- Cleanroom Manufacturing
- Biologics
- Pre-Filled Syringes
- Auto-injector Development
- Inhalation Product Development
- FDA
- Design Control
- ISO 13485
- Quality System
- Regulatory Requirements
- Product Launch
- Human Factors Engineering
- Drug Delivery
- CAPA
- Cross-functional Team Leadership
- Syringe
- Validation
- Engineering
- Manufacturing
- Packaging
- Technology Transfer
- GMP
- Pharmaceutical Industry
- Product Development
- Regulatory Affairs
- Management
- V
- V&V
- Biotechnology
- Biopharmaceuticals
- Corrective and Preventive Action (CAPA)
- U.S. Food and Drug Administration (FDA)
- Verification and Validation (V&V)
- Development
- Human Factors
- Inhalation Product
- Cross Functional Team
- Verification And Validation V&V
- Pre Filled Syringes
- Corrective And Preventive Action Capa
- Strategic Planning
- Program Management
- Cross Functional Team Leadership
- Customer Service
- U.S. Food And Drug Administration Fda
- Auto Injector Development
- Auto Injector
- Device Development
- Qualification
- Electro Mechanical
- Creams
- Liquids
- Device Design
- Safety
- Business Strategy
- Combination
- Core Technology
- Usability Engineering
- Testing
- Pharmaceutics
- Medicine
- Connected Health
- Forms
- Mechanical Engineering
- Master Plan
- Assembly
- Responsibility
- Filing
- Auto
- Container
- Rate
- Applications
- Functional Verification
- Negotiation
- Technology Evaluation
- Injection Molding
- Supplier Relationship Management
- Facilities Management
- Project
- Start Ups
- Final Assembly
- Ep
- Risk Management
- International
- Commercial Real Estate
- Particle Size
- Data Conversion
- Troubleshooting
- Spray
- Molding
- Inspiration
- Initiation
- Plastics
- Facility Master Planning
- Guidance
- Trials
- Direct Management
- Marketing
- Technical Aspects
- Suppliers
- Guidelines
- Nasal
- Distribution Center Operations
- Patient
- Design History
- Patents
- Design
- Dry
- Mechanical
- Usability Testing
- System
- Rheumatoid Arthritis
- Jersey
- Sensors
- Prototype
- Autoinjectors
- Technical Support
- Regulatory Compliance
- Aseptic
- Tablets
- Powder
- Cascade
- Cfr
- Project Estimation
- Aerosol
- Closure
- Fabricate
- Isolators
- Contract Engineering
- Complaint Management
- Inventory Control
- Internal Controls
- LCD
- User Requirements
- Operations
- Multi Site Manufacturing
- Training
- R&d
- Sub Assembly
- Respiration
- Alternate
- Human Resources
- Inspection
- Justification
- Strategy
- Drafting
- Delivery
- ISO 14971
- European Union
- Image Capture
- Technical Services
- SQL
- Microprocessors
- Contract Management
- Method Transfer
- Product Transfer
- Electronics
- Injectable
- Engineering Support
- Due Diligence
- Net
- Stage
- Connected Devices
- Evaluation
- Contract Manufacturing
- Harmonization
- Standardization
- Commercialization
- Public Speaking
- Assembly Automation
- CAP
- Dosing
- CMC
- Supply
- Platforms
- Modification
- Stakeholders
- Contractual Agreements
- Science
- Insulin
- Inhalation
- Auditing
- Qualify
- Mechanics
- Subcutaneous
- Regulations
- Class Ii
- Concepts
- Compliance
- Remediation
- Cost
- Technical Operations
- Internal Audit
- Clinical Research
- A2
- Building Management Systems
- Lead Development
- u.s. Food and Drug Administration
- Corrective and Preventive Action
- Verification and Validation
Michael Denzer Summary
- Michael Denzer, based in New York, NY, US, is currently a VP Client Relations at EdgeOne Medical. Michael Denzer brings experience from previous roles at Civica Rx, Kymanox, Teva Pharmaceuticals and Shire. Michael Denzer holds a 1995 - 1997 Bachelor of Science (BS) in Pi Tau Sigma - International Mechanical Engineering Honor Society, ASME - American Society of Mechanical Engineers - Past Pres & V Pres - NJIT student chapter @ New Jersey Institute of Technology. With a robust skill set that includes Combination Products, Drug Delivery Systems, Parenteral, Packaging Engineering, Medical Devices and more. Michael Denzer has 2 emails and 3 mobile phone numbers on RocketReach.
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