ROLE SUMMARY
pMDI Product Development Scientist required to support multiple metered dose inhaler NPI projects.
This is an exciting role as a pMDI Product Development Scientist required to support multiple metered dose inhaler NPI projects withinan expanding team of process and product development specialists and offers the successful candidate an opportunity to make a significant contribution to the development of new inhalation products and future technologies by applying their creative technical skills and scientific experience to solve complex technical challenges.
Support to pMDI product development activity from early development to registration for NPI projects
Provision of support for all functional data analysis and documentation activities from early development through to final submission of regulatory dossiers
ROLE RESPONSIBILITIES
- Plan, organise, assist/lead product development activities for Development Pharmaceutics, Stability, Specification and Data Analysis activities for pressurised metered dose inhaler NPI programmes
- Delivery of protocols, data interpretation and reports from early development to submission to Regulatory Authorities (including IND/IMPD/MAA/NDA submissions).
- Support to activities at Laboratory, GMP, Pilot and Commercial scale
QUALIFICATIONS
- Bachelors degree or higher in Science based or Mathematics/Statistics based subjects from an accredited university.
- 2+ years of inhalation development experience. (preferably pMDI)
- Demonstrated ability to develop and define product development documentation for inhalation products
- Demonstrated data analysis and interpretation skills.
- Demonstrated strong oral and written communication skills.
- Able to multitask and remain flexible to changing project priorities.
- Work well both as an individual and in a team environment.
- Has a think outside the box mentality and is passionate about technical problem solving.
Preferred Experience
- Familiar with CMC Documentation (IND/NDA, CTA/MAA)
- Familiar with metered dose inhaler products
Familiar with QbD, design controls and product risk assessments
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