Development Fabrication Engineer

1 day ago

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

Kindeva is a global leader in drug delivery, with over a century of experience in combination product development and manufacturing. Our state-of-the-art facilities in the US and UK enable us to deliver innovative solutions across various delivery formats.

As a Manufacturing Process Development Scientist, you will play a key role in supporting multiple metered dose inhaler NPI projects. This exciting opportunity offers the chance to contribute to the development of new inhalation products and future technologies by applying your technical skills and scientific expertise to solve complex challenges.

Key Responsibilities:

  1. Plan, organize, and lead manufacturing process development experimentation from lab to commercial scale.
  2. Develop and deliver batch manufacturing documents, protocols, data interpretation, and reports for manufacturing process transfer and scale-up.
  3. Prepare documentation for submission to Regulatory Authorities, including IND/IMPD/MAA/NDA submissions.
  4. Analyze and interpret data to support manufacturing process development activities, enabling CQA/CPP & specification development.
  5. Develop and define manufacturing process development strategies for inhalation products, with a focus on pMDI pressure filling processes.
  6. Apply data analysis and interpretation skills to drive manufacturing process development.
  7. Communicate effectively through strong oral and written skills.
  8. Multitask and adapt to changing project priorities.
  9. Work collaboratively in a team environment.
  10. Familiarity with cGMP manufacturing environments and a passion for technical problem-solving.

Preferred Qualifications:

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

What We Offer:

  1. An attractive compensation package.
  2. A company pension scheme with up to 10% employer contribution and 25 days holiday per year.
  3. Company sick pay and an Employee Assistance Program with 24/7 confidential helpline support.
  4. Life assurance of four times life cover salary and wellness programs.
  5. Employee recognition program and free on-site parking.
  6. Discounts and cashback at many retailers and a cycle to work scheme.

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