Our client based in Cambridge is looking to appoint an experienced Device Development Scientist with Drug Delivery expertise. The job requires close working with multidisciplinary teams comprising Design, Mechanical, Quality, Compliance Regulatory, Human Factors and formulation Engineers and Scientists, who are working on drug delivery device development / testing.
Major Duties:
- Works as part of a multidisciplinary team to determine what performance factors of the drug delivery device will require assessment and investigation.
- Support interactions with external vendors and internal partners within the following activities: design verification, shelf life studies, shipping studies, and manufacturing process qualification for drug delivery devices
- Assist preparation of regulatory submissions, internal and external audits.
- Apply statistical, scientific and engineering expertise and research experience to solve problems creatively and independently and support decision making.
- Apply method development and method validation principles to the qualification and use of bespoke test equipment.
- Uses analytical and statistical tools to analyse the data in order to quantify the functional performance characteristics of the drug delivery device, the controlling parameters for its consistent performance, etc.
- Able to define appropriate approaches to quantify design parameters, including design of experiments and statistical interpretation of data.
- Performs other duties as assigned in support of business goals e.g. hands-on testing.
Person Specification
Education
Essential Attributes
- Degree, HND or equivalent in relevant Science or bioengineering subject.
Desirable Attributes
- Evidence of sustained level of achievement.
- Good theoretical knowledge and understanding of academic subjects.
Experience
Essential Attributes
- Previous experience of working with device design control system life cycle and drug delivery device testing.
- Working experience of test method development and validation
- Good knowledge of mechanical and/or electronic testing of drug delivery device
- 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.
Desirable Attributes
- In depth statistical data analysis skills
- Preferred deep knowledge and application of following standards in the work experience - Guidance, Design Controls, ISO 11608, ISO 13485, ISO 14971, IEC 60601, ASTM 4149 and ISTA 2 series, GMP/GLP
Technical Ability
Essential Attributes
- Good standard of written and spoken English and numeracy.
- Previous experience within drug delivery medical device or Pharmaceutical industry.
- Logical and intuitive thinker
- Able to communicate with others outside team/group.
- Able to learn and apply established procedures in a reliable and consistent manner.
- Evidence of productivity, speed and quality.
- Able to communicate to a team, in an appropriate oral and/or written format, the outcome of any investigations.
Desirable Attributes
- Literature searching and distillation and application of findings, (where appropriate).
Presentation
Essential Attributes
- Able to anticipate what information is required by their colleagues and to disseminate it actively and efficiently.
Desirable Attributes
- Able to prepare and present data to technical colleagues in a succinct and informative way
Motivation
Essential Attributes
- Enjoys working within multidisciplinary teams in the development of leading edge designs and technologies
Desirable Attributes
- Desire to contribute to product and process development of pharmaceuticals
Personal Characteristics
Essential Attributes
- Takes pride in the quality of their work.
- Effective team worker.
- Ability to plan, organise and prioritise own work
- Comfortable working to agreed deadlines.
- Able to work with limited supervision
- Willing to listen and take advice from others.
- Has good communication skills.
- Good attention to detail.
- Capable consistently of accurate recording of all data in compliance with SOPs.
Desirable Attributes
- Ability to adapt to change.
- Flexible and resilient.
- Shows initiative and has ability to think for self.
- Strives for quality and excellence in own work and others
- Ability to work/interact with a range of people.
- Plans ahead (1-2 months)
Circumstances
- Able to travel or relocate to Cambridge area
- Flexible attitude to working hours if the job demands this from time to time.
- Positive attitude to animal experimentation