Ronan HUET

- Support to QC through optimisation, troubleshooting, validation and implementation of drug product Potency assay, Purity determination and Dissolution methods (HPLC, UV), inc. for manufacturing process optimisation.
- Preparation and execution of Analytical Method Transfer Exercise from/to company site (Iceland, Indonesia).
- Pharmacopoeial reviews (EP).
- Execution of cleaning validation exercises using SPE.

Development and stability testing of inhalation drug products (5.5 yrs), drug substances (1 yr) and sustained release drug products (1 yr).

- Development (inc. QbD), optimisation, validation and implementation of analytical methods (inc. 1 yr on protein)
- Management of project activities, set-up/management of internal and outsourced stability studies, preparation/execution of Designs of Experiment
- Support to synthetic chemistry group, inc. structure elucidation by MS
- Management and execution of Analytical Method Transfer Exercise to company site, co-development company, and CROs (USA, UK, France), inc. training of company staff and instrument troubleshooting.
- Empower super-user (2.5 yrs) and trainer (1.5 yr)
- HPLC coordinator (2.5 yrs) and laboratory coordinator (6 months)

Tests and Techniques:
* Potency assay (inc. High Molecular Weight Protein content by SEC)
* Purity determination (drug substance and drug product)
* Emitted Dose (DUSA, Apparatus B)
* Aerodynamic Particle Size Distribution (NGI, Apparatus 5&6)

* UHPLC (5 years, including Agilent 1200 SL/Waters UPLC Acquity)
* HPLC (Agilent 1100, Waters Alliance, Shimadzu, Jasco)
* LC-MS and UPLC-MS/MS (Single and Triple Quad., Q-TOF, Ion Trap)
* UV spectrophotometry
* RAMAN spectroscopy (PhAT probe)

Publication: Chromatography Today (2011), 17 (co-author).

Implementation & optimisation of analytical methods: dissolution in stability testing of sustained release drug products.

Implementation of analytical methods: UV, FT-IR, TLC for batch release of cytotoxic drug substances.

Implementation and transfer of analytical methods: HPLC, Dissolution, CE for batch release and stability testing of drug substance and sustained release drug products.




Other relevant experience available on CV.