Product Development Scientist

Posted Monday, September 23, 2024 at 5:00 AM With over a century of experience in combination product development and manufacturing, Kindeva is truly a global force in drug delivery. We have state of the art facilities across the US and UK and our capabilities span delivery formats, from ideation through commercialisation. Summary of Position This is an exciting role as a pMDI Product Development Scientist required to support multiple metered dose inhaler NPI projects within an expanding team of process and product development specialists. This position 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. Job 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 activities at Laboratory, GMP, Pilot and Commercial scale. Support 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. 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. Minimum Requirements Bachelors degree or higher in Science based or Mathematics/Statistics based subjects from an accredited university. 2+ years of inhalation development experience (preferably pMDI). Preferred Experience Familiar with CMC Documentation (IND/NDA, CTA/MAA). Familiar with in-silico modelling and IVIVR. Familiar with metered dose inhaler products. Familiar with QbD, design controls and product risk assessments. What we will give to you: Attractive compensation package. Company pension scheme (up to 10% employer contribution) and 25 days holiday per year (plus bank holidays) plus service days after 5 years. Company sick pay. Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family. Life assurance of four times life cover salary.

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