Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives.
It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds.
Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List.
Today, at least 200 million people around the world take one of our medicines every single day.
An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
The Opportunity We would like to invite applications for the role of an permanent Lead Product Development Scientist position at our Waterford Site.
Key Responsibilities Leading the development and manufacture of inhaled drug delivery systems, including dry powder inhalers and pressurised metered-dose inhalers (pMDIs).
Inputting into manufacturing processes strategies from concept through scale up to commercialisation.
Design and develop novel formulations for inhaled drug delivery systems, including dry powder inhalers and pressurised metered-dose inhalers (pMDIs).
Responsible for identifying Critical Process Parameters (CPPs) through Design of Experiments studies and developing robust manufacturing processes using Quality by Design (QbD) and Quality Risk Management (QRM) principles.
Developing professional relationship with TGO and lead process technical transfers to commercial partners including pre-submission process validations manufacturing if required.
Preparing and review documentation for regulatory submissions (IND, NDA, ANDA, etc.) Working as an integral member of a larger team alongside Formulation Pre-formulation and reverse engineering of products identifying Critical Material Attributes (CMAs) and Critical Quality Attributes (CQAs).
Use contemporary Design of Experiments (DoE), data analysis and risk management techniques to assess development strategies and prioritize activities.
Work as part of a team who will be responsible for overall product development of novel respiratory therapies from concept through to clinical trials and commercialisation.
Identification of innovative opportunities to support process and formulation optimisation approaches.
Your Experience And Qualifications Are you .
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Bachelors, Masters or PhD qualified in physical sciences, chemical engineering (or related subjects) Bringing industry experience within a Pharmaceutical R