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Drug Delivery Device Development Senior Scientist

Cambridgeshire   •  Negotiable  •  Permanent, Full time


Drug Delivery Device Development Senior Scientist

12 months

Cambridge

Pay rates :- PAYE up to 24.84 p/h or Umbrella up to 27.84 p/h

CPL Life Sciences are looking for a contractor on a 12 month basis. The successful candidate will be representing as Subject Matter Expert in device development and must demonstrate knowledgeand background in analytical method development, design verification, specification setting and stability testing for drug delivery devices. The job requires close working with multidisciplinary teams comprising Design, Mechanical, Quality, Compliance Regulatory, Human Factors andformulation Engineers and Scientists, who are working on drug delivery device development / testing.

Main Duties:

  • Works as part of a multidisciplinary team to determine what performance factors of the drug delivery device will require assessment and investigation.
  • Work with project lead as a subject matter expert and lead technical support for the following activities:
  • Technical SME in testing related activities to support the design and development of medical devices and combination products (MDCP).
  • Leading DDS technical support for new product design and development,
  • Leading design verification, analytical control strategy;
  • Assist development of inspection and test procedure to ensure that incoming, in-process, and finished products meet functional specifications and quality standards.
  • Provide essential supports for regulatory submissions.
  • Work with third-party suppliers and vendors and other key stakeholders.
  • Apply scientific and engineering expertise and experience to solve problems and perform statistical analyses of data to lead the support for decision making
  • Plan own tasks for to ensure timely completion

Education, Skills & Experience

  • Degree (preference advanced degree) in Pharmacy, Pharmaceutical Sciences, Mechanical Engineering (or similar disciplines).

    • In-depth knowledge in drug-device combination product research and development
    • 5+ years direct experience in pharmaceutical development and/or medical device development including manufacturing process development and scale up to commercial production.
    • Familiar with techniques, tools and technologies, standards and guidance for medical device design verification activities and analytical control strategy.
    • Strong statistical data analysis skills
    • Thorough knowledge of industry standards, FDA guidance, quality systems, verification, validation for medical devices and combination products
    • Demonstrated ability to create and execute to technical plans and timelines

  • Agency: Cpl Life Sciences
  • Reference: JO-2205-493498
  • Posted: 18th July 2022
  • Expires: 15th August 2022

Cpl Life Sciences

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