Manufacturing Process Development Scientist

2 weeks ago


Loughborough, Leicestershire, United Kingdom Kindeva Full time
Manufacturing Process Development Scientist

Kindeva is a global leader in drug delivery, with state-of-the-art facilities across the US and UK. We are seeking a Manufacturing Process Development Scientist to support multiple metered dose inhaler NPI projects.

The successful candidate will have the 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.

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).
  6. Demonstrated data analysis and interpretation skills.
  7. Demonstrated strong oral and written communication skills.
  8. Able to multitask and remain flexible to changing project priorities.
  9. Work well both as an individual and in a team environment.
  10. Familiar with working in a cGMP manufacturing environment.
  11. Has a think outside the box mentality and is passionate about technical problem solving.

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.

What we offer:

  1. Attractive compensation package.
  2. Company pension scheme (up to 10% employer contribution) and 25 days holiday per year (plus bank holidays) plus service days after 5 years.
  3. Company sick pay.
  4. Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family.
  5. Life assurance of four times life cover salary.
  6. Wellness programmes.
  7. Employee recognition program.
  8. Free on-site parking.
  9. Discount and cashback at many retailers.
  10. Cycle to work scheme.


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