Manufacturing Process Development Scientist

1 month ago


Loughborough, Leicestershire, United Kingdom Kindeva Drug Delivery Full time

Job Summary

We are seeking a skilled Manufacturing Process Development Scientist to support multiple metered dose inhaler NPI projects. This role offers the successful candidate an opportunity to make a significant contribution to the development of new inhalation products and future technologies.

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.

Requirements

  • Bachelors 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.
  • Work well both as an individual and in a team environment.
  • 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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