Lead Product Development Scientist

Lead Product Development Scientist

Teva

Waterford, Ireland

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….

• Bachelors, Masters or PhD qualified in physical sciences, chemical engineering (or related subjects);
• Bringing industry experience within a Pharmaceutical R&D based Scientist role;
• Experienced in process development, drug product manufacturing and process scale-up is essential.

Do you have….

• Experience in DoE design, data modelling and risk management would be beneficial;
• The ability to work as a flexible member of a project team, be quality orientated, be aware and work to tight deadlines;
• Adaptable personality-able to work with changing priorities and the flexibility to re-prioritise work schedule;
• Excellent verbal and written communication, organisational skills and computer skills.