Michael Denzer Email & Phone Number

Principal

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Michael Denzer Location

New York, NY, US

Michael Denzer Work

Principal @ Combination Product Associates, LLC (October 2026 - Present)
VP Client Relations @ (July 2025 - October 2026)
Head - Device and Packaging Engineering, Biosimilars @ (January 2023 - May 2025)
Vice President - Client Success @ (March 2019 - January 2023)
Sr. Director - Biologics Devices and Combination Product Development @ (October 2017 - March 2019)
Head - Device External Operations @ (September 2016 - August 2017)
Director - Commercial Devices and Combination Products @ (October 2015 - September 2016)
Mentor -Robotics Team 3637, "The Daleks" @ FIRST (August 2016 - May 2017)
Director - Device Development and Technology @ (July 2011 - June 2015)
Sr. Manager - Engineering - Packaging and Device Development @ (February 2007 - June 2011)
Principal Engineer - Packaging and Equipment Development @ (January 2004 - January 2007)
Engineer - Packaging and Assembly Equipment Development @ (January 1995 - January 2004)

Michael Denzer Education

New Jersey Institute of Technology
Bachelor of Science (BS) (Mechanical Engineering)
1995-1997

Michael Denzer Skills

Auto-injector Development
Biologics
Biopharmaceuticals
Biotechnology
Business Management
Business Strategy
CAPA
CMO management
CMO selection
Cleanroom Manufacturing
Client Relations
Combination Products
Connected Devices
Connected Health
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
Customer Relationship Management (CRM)
Customer Service Management
Design Control
Drug Delivery
Drug Delivery Systems
Drug Development
Engineering
Engineering
Engineering Management
FDA
GMP
Human Factors Engineering
IND
ISO 13485
Inhalation Product Development
Management
Manufacturing
Medical Devices
New Drug Application (NDA)
Packaging
Packaging Engineering
Parenteral
Pharmaceutical Industry
Pre-Filled Syringes
Product Development
Product Launch
Product Strategy
Program Management
Quality System
Regulatory Affairs
Regulatory Requirements
Strategic Planning
Supplier Relationship Management
Syringe
Technology Transfer
U.S. Food and Drug Administration (FDA)
V&V
Validation
Verification and Validation (V&V)
autoinjectors
prefilled syringe
V
Development
Human Factors
Inhalation Product
Cross Functional Team
Verification And Validation V&V
Pre Filled Syringes
Corrective And Preventive Action Capa
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
Combination
Core Technology
Usability Engineering
Testing
Pharmaceutics
Medicine
Forms
Mechanical Engineering
Master Plan
Assembly
Responsibility
Filing
Auto
Container
Rate
Applications
Functional Verification
Negotiation
Technology Evaluation
Injection Molding
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
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
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 Principal at Combination Product Associates, LLC. Michael Denzer brings experience from previous roles at EdgeOne Medical, Civica Rx, Kymanox and Teva Pharmaceuticals. Michael Denzer holds a 1995 - 1997 Bachelor of Science (BS) in Mechanical Engineering @ New Jersey Institute of Technology. With a robust skill set that includes Auto-injector Development, Biologics, Biopharmaceuticals, Biotechnology, Business Management and more. Michael Denzer has 1 emails and 3 mobile phone numbers on RocketReach.