Manufacturing Process Development Scientist

5 days ago

Loughborough, Leicestershire, United Kingdom Kindeva Drug Delivery Full time
Job Title: Manufacturing Process Development Scientist

We are seeking a highly skilled Manufacturing Process Development Scientist to join our team at Kindeva Drug Delivery. As a key member of our process development team, you will be responsible for planning, organizing, and executing manufacturing process development experimentation from lab to commercial scale.

Key Responsibilities:
  • Plan and execute manufacturing process development experimentation from lab to commercial scale.
  • Develop and deliver batch manufacturing documents, protocols, data interpretation, and reports for manufacturing process transfer and scale-up from lab to commercial scale.
  • Ensure the delivery of documentation required for submission to Regulatory Authorities, including IND/IMPD/MAA/NDA submissions.
  • Analyze and interpret data to support manufacturing process development activities, enabling CQA/CPP & specification development.
Requirements:
  • Bachelor's degree or higher in a Science-based or Process/Chemical Engineering-based subject from an accredited university.
  • At least 2 years of experience in inhalation process development, preferably with pMDI products.
  • Demonstrated ability to develop and define manufacturing process development strategy for inhalation products, ideally for pMDI pressure filling processes.
  • Strong data analysis and interpretation skills.
  • Excellent oral and written communication skills.
  • Able to multitask and remain flexible to changing project priorities.
  • Experience working in a cGMP manufacturing environment.
  • Think outside the box mentality and passion for technical problem-solving.
Preferred Qualifications:
  • Familiarity with pressure filling of metered dose inhaler products.
  • Familiarity with QbD, design controls, and process risk assessments.
  • Familiarity with CMC Documentation (IND/NDA, CTA/MAA).
  • Familiarity with statistical evaluation of data, modeling, and reporting.
What We Offer:
  • 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 programs.
  • Employee recognition program.
  • Employee development.
  • Free on-site parking.
  • Discount and cashback at many retailers.
  • Cycle to work scheme.
  • Flu vaccinations.

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