Scientific Process Development Specialist
16 hours ago
Job Title: Scientific Process Development Specialist
">About the RoleWe are seeking an experienced Scientific Process Development Specialist to join our expanding team of process and product development specialists.
">Key Responsibilities- Plan, organise, assist/lead manufacturing process development experimentation from lab to commercial scale.
- Delivery of batch manufacturing documents, protocols, data interpretation, and reports for manufacturing process transfer and scale-up from lab to commercial scale.
- Delivery of documentation required for submission to Regulatory Authorities (including IND/IMPD/MAA/NDA submissions).
- Data analysis and interpretation to support manufacturing process development activities enabling CQA/CPP & specification development.
- Demonstrated ability to develop and define manufacturing process development strategy for inhalation products (ideally for pMDI pressure filling processes).
Preferred Qualifications:
- Familiar with pressure filling of metered dose inhaler products.
- Familiar with QbD, design controls, and process risk assessments.
- Familiar with CMC Documentation (IND/NDA, CTA/MAA).
- Familiar with statistical evaluation of data, modelling, and reporting.
Benefits Package:
- Competitive compensation package (£65,000 - £80,000 per annum)
- 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
This is an exciting opportunity to make a significant contribution to the development of new inhalation products and future technologies by applying your creative technical skills and scientific experience to solve complex technical challenges.
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