David Kukelko
Senior Engineer - Manufacturing Sciences & Technology at Emergent BioSolutions | Winnipeg, Manitoba, Canada
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David Kukelko is a seasoned Senior Engineer in Manufacturing Sciences & Technology at Emergent BioSolutions, where he leverages his extensive background in the pharmaceuticals industry to drive innovation and operational excellence. With a strong focus on Good Manufacturing Practice (cGMP) and aseptic processing, David plays a pivotal role in ensuring that the company’s biopharmaceutical products meet the stringent regulatory standards set by the U.S. Food and Drug Administration (FDA). His expertise extends to tech transfer and scale-up processes, where he assesses facility fit and oversees the generation of protocols, execution, and reporting to ensure seamless transitions from development to production.
Currently, David leads the Site Global Serialization Project, a critical initiative aimed at enhancing product traceability and compliance across the supply chain. His proactive approach to risk management, utilizing methodologies such as Failure Mode and Effects Analysis (FMEA), Hazard and Operability Study (HAZOP), and Hazard Analysis and Critical Control Points (HACCP), underscores his commitment to maintaining the highest safety and quality standards in manufacturing operations. Additionally, David's involvement in process transfer and materials management for Ready-to-Use (RTU) isolators showcases his ability to integrate cutting-edge technologies into existing workflows, optimizing efficiency and product integrity.
With a strong foundation in Research and Development (R&D) and a CRM focused on Risk Management from The University of Winnipeg, David combines technical acumen with strategic insight, making him an invaluable asset to Emergent BioSolutions. His dedication to continuous improvement and operational excellence positions him as a leader in the biopharmaceutical sector, driving initiatives that not only enhance productivity but also ensure the delivery of safe and effective therapies to patients worldwide.
Senior Engineer - Manufacturing Sciences & Technology at Emergent BioSolutions in January 2014 to Present
Engineering & Process Support - Principal Engineer at Cangene Corporation in April 2011 to January 2014
Manufacturing Sciences and Technology, Engineering Manager at Cangene Corporation in September 2010 to April 2011
Process Engineering Manager at Cangene Corporation in January 2002 to September 2010
Engineering Manager at Cangene Corporation in January 1998 to January 2002
Validation and Engineering – Assistant Manager at Cangene Corporation in January 1996 to January 1998
Validation Technician at Cangene Corporation in January 1994 to January 1996
Repair Engineer at Standard Aero in January 1990 to January 1993
Technical Marketing Engineer at Monarch Industries in January 1987 to January 1989
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The University of Winnipeg, CRM, August 2026
University of Manitoba, August 1983 to August 1987
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FDA
Validation
Manufacturing
Commissioning
Biotechnology
Process Engineering
GMP
Engineering
Testing
Instrumentation
Risk Management
Fermentation
Automation
Troubleshooting
Biopharmaceuticals
Process Simulation
Change Control
V&V
Aseptic Processing
Technology Transfer
CAPA
Sop
Filtration
R&D
Chromatography
Quality System
Cleaning Validation
GAMP
21 CFR Part 11
Design of Experiments
Purification
GLP
Lifesciences
Pharmaceutical Industry
HPLC
Team Management
Project Management
SOP
Life Sciences
Standard Operating Procedure (SOP)
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
Research and Development (R&D)
Good Laboratory Practice (GLP)
Verification and Validation (V&V)
Personal Development
Team Motivation
Performance Motivation
Communication
Active Listening
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Discover more about Emergent BioSolutionsWhat is David Kukelko email address?
Email David Kukelko at [email protected] and [email protected]. This email is the most updated David Kukelko's email found in 2026.
How to contact David Kukelko?
To contact David Kukelko send an email to [email protected] or [email protected]. (updated on September 30, 2024)
What company does David Kukelko work for?
David Kukelko works for Emergent BioSolutions
What is David Kukelko's role at Emergent BioSolutions?
David Kukelko is Senior Engineer - Manufacturing Sciences & Technology
What is David Kukelko's Phone Number?
David Kukelko's phone (416) ***-*215
What industry does David Kukelko work in?
David Kukelko works in the Pharmaceuticals industry.
David Kukelko Email Addresses
David Kukelko Phone Numbers
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