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Scientific Device Development Specialist
2 months ago
Job Overview:
As a key member of our team at Next Phase Recruitment Limited, we are seeking a highly skilled Scientific Device Development Specialist to join our multidisciplinary team. This is a Contract position that requires a strong background in drug delivery device development and a proven track record of working accurately and within agreed deadlines.
Key Responsibilities:
- Collaborate with our design, mechanical, quality, compliance regulatory, human factors, and formulation engineers and scientists to determine the performance factors of drug delivery devices that require assessment and investigation.
- 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 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.
- Use analytical and statistical tools to analyze data and quantify the functional performance characteristics of drug delivery devices, controlling parameters for consistent performance, etc.
- Define appropriate approaches to quantify design parameters, including design of experiments and statistical interpretation of data.
- Perform other duties as assigned in support of business goals, including hands-on testing.
Requirements:
- Strong background in drug delivery device development.
- Proven track record of working accurately and within agreed deadlines.
- Excellent communication and collaboration skills.
- Ability to work independently and as part of a multidisciplinary team.
- Strong analytical and problem-solving skills.
