Process Development Engineer for Metered Dose Inhalers
3 weeks ago
We are seeking a highly skilled Manufacturing Process Development Scientist to join our team at Kindeva Drug Delivery. As a key member of our process and product development team, you will play a critical role in the development of new inhalation products and future technologies.
Key Responsibilities- Plan, organize, and lead manufacturing process development experimentation from lab to commercial scale.
- Develop and deliver batch manufacturing documents, protocols, data interpretation, and reports for manufacturing process transfer and scale-up from lab to commercial scale.
- Prepare and submit documentation required for regulatory authorities, including IND/IMPD/MAA/NDA submissions.
- Analyze and interpret data to support manufacturing process development activities, enabling CQA/CPP & specification development.
- Bachelor's degree or higher in a science-based or process/chemical engineering-based subject from an accredited university.
- At least 2 years of experience in inhalation process development, preferably with pMDI products.
- Demonstrated ability to develop and define manufacturing process development strategies for inhalation products, ideally for pMDI pressure filling processes.
- Strong data analysis and interpretation skills.
- Excellent oral and written communication skills.
- Able to multitask and remain flexible to changing project priorities.
- Experience working in a cGMP manufacturing environment.
- Think outside the box mentality and passion for technical problem-solving.
- Familiarity with pressure filling of metered dose inhaler products.
- Familiarity with QbD, design controls, and process risk assessments.
- Familiarity with CMC documentation (IND/NDA, CTA/MAA).
- Familiarity with statistical evaluation of data, modeling, and reporting.
- Attractive compensation package.
- Company pension scheme (up to 10% employer contribution).
- 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.
- Flexible working hours.
- Wellness programs.
- Employee recognition program.
- Employee development.
- Free on-site parking.
- Discount and cashback at many retailers.
- Cycle to work scheme.
- Flu vaccinations.
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