Scientific Process Development Specialist

16 hours ago


Loughborough, Leicestershire, United Kingdom Kindeva Drug Delivery Company Full time

Job Title: Scientific Process Development Specialist

">About the Role

We are seeking an experienced Scientific Process Development Specialist to join our expanding team of process and product development specialists.

">Key Responsibilities
  1. Plan, organise, assist/lead manufacturing process development experimentation from lab to commercial scale.
  2. Delivery of batch manufacturing documents, protocols, data interpretation, and reports for manufacturing process transfer and scale-up from lab to commercial scale.
  3. Delivery of documentation required for submission to Regulatory Authorities (including IND/IMPD/MAA/NDA submissions).
  4. Data analysis and interpretation to support manufacturing process development activities enabling CQA/CPP & specification development.
  5. Demonstrated ability to develop and define manufacturing process development strategy for inhalation products (ideally for pMDI pressure filling processes).

Preferred Qualifications:

  1. Familiar with pressure filling of metered dose inhaler products.
  2. Familiar with QbD, design controls, and process risk assessments.
  3. Familiar with CMC Documentation (IND/NDA, CTA/MAA).
  4. Familiar with statistical evaluation of data, modelling, and reporting.

Benefits Package:

  1. Competitive compensation package (£65,000 - £80,000 per annum)
  2. Company pension scheme (up to 10% employer contribution)
  3. 25 days holiday per year (plus bank holidays) plus service days after 5 years
  4. Company sick pay
  5. Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family
  6. 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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