Clinical Development Scientist

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time
Job Title: Clinical Development Scientist

We are seeking an experienced Clinical Development Scientist to join our team in Cambridge. As a key member of our multidisciplinary team, you will be responsible for determining the performance factors of drug delivery devices and working closely with design, mechanical, quality, compliance regulatory, human factors, and formulation engineers and scientists.

Key Responsibilities:
  • Support interactions with external vendors and internal partners in design verification, shelf life studies, shipping studies, and manufacturing process qualification for drug delivery devices.
  • Assist in the preparation of regulatory submissions and internal and external audits.
  • Apply statistical, scientific, and engineering expertise to solve problems creatively and independently and support decision making.
  • Develop and validate test methods for the qualification and use of bespoke test equipment.
  • Analyze data to quantify the functional performance characteristics of drug delivery devices and their controlling parameters.
  • Define approaches to quantify design parameters, including design of experiments and statistical interpretation of data.
Requirements:
  • Degree, HND, or equivalent in a relevant science or bioengineering subject.
  • Good theoretical knowledge and understanding of academic subjects.
  • Previous experience of working with device design control systems and drug delivery device testing.
  • Working experience of test method development and validation.
  • Good knowledge of mechanical and/or electronic testing of drug delivery devices.
  • Experience of working in teams in the development or troubleshooting of drug delivery devices, analytical methodology, or manufacturing processes.
Preferred Qualifications:
  • Deep knowledge and application of standards such as Guidance, Design Controls, ISO 11608, ISO 13485, ISO 14971, IEC 60601, ASTM 4149, and ISTA 2 series, GMP/GLP.
  • Good standard of written and spoken English and numeracy.
  • Previous experience within the drug delivery medical device or pharmaceutical industry.
  • Evidence of productivity, speed, and quality.

We are looking for a motivated and detail-oriented individual who is able to work with limited supervision and consistently record accurate data in compliance with SOPs. If you are a team player with a passion for scientific research and development, we encourage you to apply for this exciting opportunity.

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