Device Analytical Manager, Dublin, Ireland
Posted on 30/01/17
At Mylan, we mean it when we say we work every day to provide access to high quality medicine to the world’s 7 billion people. If you are unconventional, relentless and passionate.
If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you.
Device Analytical Manager
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 organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe.
We develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and work across Mylan to support innovative technology solutions to provide healthcare solutions for 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
At Mylan, each person has the ability to make a difference.
From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role.
Here’s how this role will help:
The successful candidate will join the Global Device Development (GDD) within R&D as Device Analytical Manager within the Device and Product Performance group.
- Lead team to set up a new device testing laboratory in Dublin. Set up will include facility and utility preparation, equipment qualification of off the shelf and Bespoke device testing equipment, development of test methods and training of analysts
- Work with the project teams within Global Device Development to design and execute protocols that meet regulatory requirements to support Engineering and Design Verification, device stability, Extractables and Leachables, Biological Evaluation and Device control strategy
- Develop device verification test plans in line with ISO 11608 and ISO 11040 and other relevant regulatory guidelines. Participate in design reviews throughout the device product lifecycle by identifying and addressing any analytical gaps and providing technical expertise to the project lead
- Review and interpretation of analytical data in line with study protocol objectives. Trending and statistical analysis of analytical data and compilation of technical reports to support design and development lifecycle
- Represent the device and product performance group on cross functional teams both internally within GDD and externally collaborations, partnerships or internal projects with the respiratory and Biologics group within Mylan
- Vendor management. Work with external laboratories to ensure study protocols are executed in line with GDD requirements including quality and regulatory requirements
- Author and/or review and approval of protocols, technical reports, SOPs, analytical test methods and specifications. Compilation of technical documentation for regulatory submissions
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 minimum qualifications for this position:
- The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast paced environment
- Degree in Science/Engineering with a minimum of five years experience
- Previous experience of working within a medical device environment on PFS, injectable or respiratory products
- Previous experience in setting up a new laboratory and supervisory or management experience
- Understanding of Design Control requirements and working within a GMP controlled regulatory environment. A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage
- Highly driven and motivated person who has the ability to work as part of a flexible, dynamic team whilst taking responsibility for individual tasks
- It is essential that the candidate will be both highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams. In addition the candidate must be able to work under pressure and have a proven track record of problem solving and effective time management
- Some travel time will be required as part of this role
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 40,000 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 forward your CV and covering letter to firstname.lastname@example.org quoting “Device Analytical Manager, Dublin, Ireland” within the subject title.