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Device Analyst 14 August, 2017

For Us, It’s A Mission

Mylan is a global pharmaceutical company committed to setting new standards in healthcare.

Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership.

Our Global Device Development (GDD) organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery of our large and growing range of generic and branded products around the globe.

The technologies we develop enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and we work across Mylan to support innovative technology solutions to deliver healthcare to our patients.

We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.

Make a Difference

We are seeking a talented Device Analyst to join the growing team. The successful candidate will support the development of medical devices and combination products across the Mylan portfolio.  The role will be based in Sandwich, Kent, UK.

The successful candidate will:

  • Apply analytical knowledge and experience to provide technical expertise on areas including device control, design verification, shipping simulation and device stability; across a variety of medical devices and combination products including auto-injectors, pre-filled syringes and inhalers.
  • Represent the Device and Product Performance group on cross functional teams internally within GDD to support design control on a range of device programs, working with a wide range of functional groups including User Interface, Device Design and Industrialization and Device Development Assurance.
  • Use innovation and experience to design and implement bespoke techniques developed to meet requirements of device testing strategy. Perform mechanical and functional testing on medical devices and combination products using standard techniques.
  • Develop Design Verification test plans in line with ISO 11608 and ISO 11040 and other relevant regulatory guidelines. Participate in cross-functional design reviews throughout the device product lifecycle by identifying and addressing any analytical gaps and providing technical expertise to the project lead. Ensure all technical issues encountered are discussed with the relevant SMEs within the design and development group.
  • Review and interpret analytical data in line with study and protocol objectives. Compile technical reports to support design and development lifecycle.
  • Work with external laboratories to ensure study protocols are executed in line with GDD requirements including quality and regulatory requirements.
  • Author and/or review protocols, technical reports, SOPs, analytical test methods (including test method validation and verification) and specifications.
  • Perform device investigations and participate in GDD and technical investigation teams as required. Report and log aberrant results using Trackwise™. Troubleshoot instrumentation and investigate aberrant sample results.
  • Maintain a high standard of GMP in line with the GDD QMS ensuring audit readiness at all times.
  • Attend EHS training and maintain responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.

Make Our Values Your Values

Mylan hires only the best.

People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care.

Here are the qualifications for this position:

Essential

  • Degree in Analytical Chemistry/Chemistry/Biochemistry or equivalent, with some experience in industry
  • GMP knowledge
  • Experienced in technical report writing.
  • Proven track record of analytical laboratory experience in GxP environment
  • Experience in industry

Desirable

  • Mechanical/device testing
  • Experienced in testing of inhalation products and in particular NGI, ED testing
  • Experienced user of HPLC/UPLC
  • Experienced in analytical testing of active pharmaceutical ingredients and/or drug product
  • Experience in testing requirements for medical devices and/or combination products

Other Requirements

  • Be able to operate collaboratively across the Mylan Global Device Development organisation (i.e. not in isolation) to achieve clear goals and outcomes to advance the organisation.
  • Be able to network with other groups across the Mylan organisation.
  • Be prepared for occasional business travel/willingness to travel.

Why Mylan?

If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference.

We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care. Mylan is an Equal Opportunity Employer

To submit your application, please submit your CV and covering letter to mgrgjobs@mylan.co.uk – stating “Device Analyst – Contractor” in the subject line.

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