Manufacturing Process Development Scientist

Loughborough, England, United Kingdom

11/18/2024

With over a century of experience in combination product development and manufacturing, Kindeva is truly a global force in drug delivery. We have state of the art facilities across the US and UK and our capabilities span delivery formats, from ideation through commercialisation.

Summary Of Position

pMDI Manufacturing Process Development Scientist required to support multiple metered dose inhaler NPI projects. This is an exciting role within an expanding team of process and product development specialists and offers the successful candidate an 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.

Job 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
  
  

Minimum 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.
  
  

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
  
  

What We Will Give To You

• Attractive compensation package
• 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
• Flexible working hours
• Wellness programmes
• Employee recognition program
• Employee development
• Free on-site parking
• Discount and cashback at many retailers
• Cycle to work scheme
• Flu vaccinations
  
  

Apply Now