Biography

Over fifteen years experience of drug device development..Tengroth Consulting: Provides consultancy services concerning parenteral drug products and medical devices.

Charbel Tengroth is an experienced professional having worked in various leader roles within the fields of aseptic drug product and process development, and medical devices and combination products.
Charbel has a strong scientific background holding a PhD in physics from Chalmers Institute of Technology and post-graduate research positions at Princeton University and AstraZeneca R&D, which has given him the ability to very quickly get to the core of complex issues.

Curriculum Vitae

Summary
Inspirational leader and executive manager with expertise in aseptic drug product and process development, sterile manufacturing, and the development and production of medical devices

Career

August 2017 – present: Tengroth Consulting (owner) Independent consultant in the area of Life Sciences. Current assignments include:

• Medical device and combination products, focusing on Design Control and regulatory submission readiness.
• Strategic alignment and remediation of diverse combination product design history files, thereby enhancing compliance for over 200 products and facilitating life cycle management activities.
• Medical device development: innovate a new medical device and produce working prototypes for further testing.
• Biopharmaceutical drug manufacturing: Production support through operational excellence and continuous improvements, and production issue investigations (vaccine manufacturing) in close collaboration with Quality Assurance..