Manufacturing Process Development Specialist
3 days ago
As a Manufacturing Process Development Scientist at Kindeva Drug Delivery, you will play a crucial part in supporting multiple metered dose inhaler NPI projects. This exciting role within our expanding team of process and product development specialists offers the successful candidate an opportunity to make a significant contribution to the development of new inhalation products and future technologies.
Job Responsibilities
- Plan, organize, assist/lead manufacturing process development experimentation from lab to commercial scale.
- Deliver batch manufacturing documents, protocols, data interpretation, and reports for manufacturing process transfer and scale-up from lab to commercial scale.
- Deliver documentation required for submission to Regulatory Authorities (including IND/IMPD/MAA/NDA submissions).
- Analyze and interpret data to support manufacturing process development activities enabling CQA/CPP & specification development.
Requirements
- Bachelor's degree or higher in Science-based or Process/Chemical Engineering-based subjects from an accredited university.
- 2+ years of inhalation process development experience (preferably pMDI).
- Demonstrated ability to develop and define manufacturing process development strategy for inhalation products (ideally for pMDI pressure filling processes).
- Demonstrated data analysis and interpretation skills.
- Demonstrated strong oral and written communication skills.
- Able to multitask and remain flexible to changing project priorities.
- Familiar with working in a cGMP manufacturing environment.
- Has a think outside the box mentality and is passionate about technical problem-solving.
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