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R&D Process Development Specialist

1 month ago

Cambridge, Cambridgeshire, United Kingdom BioTalent Full time
Job Title: Device Development Scientist

Location: Onsite - Cambridgeshire, England, United Kingdom
Duration: Long-term 12 months rolling

Key Responsibilities:

As a key member of our multidisciplinary team, you will be responsible for determining the performance factors of the drug delivery device that require assessment and investigation. You will support interactions with external vendors and internal partners in activities such as design verification, shelf life studies, shipping studies, and manufacturing process qualification for drug delivery devices. Additionally, you will assist in the preparation of regulatory submissions, internal and external audits, and apply statistical, scientific, and engineering expertise to solve problems creatively and independently. You will also apply method development and method validation principles to the qualification and use of bespoke test equipment. Furthermore, you will use analytical and statistical tools to analyze data and quantify the functional performance characteristics of the drug delivery device, its controlling parameters, and other relevant factors. You will be able to define appropriate approaches to quantify design parameters, including design of experiments and statistical interpretation of data. You will perform other duties as assigned in support of business goals, such as hands-on testing.

Basic Qualifications:

Degree in a relevant Science or bioengineering subject
Previous experience within the Medical device or Pharmaceutical industry
Previous experience of working with device control system life cycle and device testing
Experience of working in teams in the development or trouble shooting of drug delivery devices, analytical methodology, or manufacturing processes by means of designed experiments and logical problem solving
Demonstrates a knowledge and background in analytical method development, design verification, specification setting, and stability testing for drug delivery devices
Good standard of written and spoken English and numeracy
Previous experience within drug delivery medical device or Pharmaceutical industry

Desirable Qualifications:

Familiar with Medical device or Pharmaceutical industry
Work experience with Guidance, Design Controls, ISO 11608, ISO 13485, ISO 14971, IEC 60601, ASTM 4149, and ISTA 2 series, GMP/GLP