About Aerogen:
Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries.
Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter.
What is the Role?
The person in this role is responsible for aerosol science testing and the development of respiratory drug delivery systems. Key responsibilities include analytical method development, chemical assay execution, project management, and ensuring lab compliance with safety and regulatory standards. The role also involves risk assessments, documentation for regulatory submissions, cross-functional collaboration, and continuous improvement.
What are the key responsibilities?
* Device Development: Lead device development efforts, including testing and validation activities.
* Analytical Methods: Lead the development, optimisation, and validation of analytical methods using techniques such as UV-Vis Spectroscopy and HPLC. Provide technical guidance and serve as a subject matter expert to support method transfer, troubleshooting, and continuous improvement initiatives.
* Chemical Assays: Develop and perform chemical assays for the quantitative determination of drug substances, ensuring accuracy, reproducibility, and compliance with regulatory standards.
* Statistical analysis: Conduct statistical tests on experimental results.
* Project Management: Manage projects to ensure timely completion to meet objectives.
* Laboratory Compliance: Ensure compliance with laboratory and health and safety standards.
* Risk Assessments: Conduct risk assessments to identify and mitigate potential issues.
* Communication and Coordination: Ensure effective communication and coordination to meet project timelines internally and for external partners.
* Regulatory Documentation: Prepare and review documentation for regulatory submissions.
* Cross-functional collaboration: Collaborate with other departments to achieve project goals.
* Troubleshooting & Problem Solving: Address and resolve lab and analytical issues during experimental work and implement corrective and preventive actions as needed.
* Continuous Improvement: Drive continuous improvement by researching and implementing advancements in analytical techniques and industry trends in aerosol science and respiratory care.
* Waste Management: Manage waste in accordance with regulatory and company standards.
* Any other duties at the request of your manager
What education and experience are required?
* Minimum Degree in a relevant discipline.
* Minimum of 5-7 years’ experience in a pharmaceutical/medical device laboratory.
What key skills will make you great at the role?
* Fluent in English, both spoken and written, with strong technical communication skills.
* Hands-on experience in the development and testing of medical devices; familiarity with inhalation drug delivery devices is a significant advantage.
* Proven ability to work effectively in multi-disciplinary teams, demonstrating initiative, independence, and experience in project management activities.
* Participate in design reviews and contribute to defining technical requirements for product development.
* Responsible for establishing, maintaining, and improving laboratory systems and processes, ensuring compliance and operational efficiency.
* Demonstrated ability to lead the development, optimisation, and validation of analytical methods using techniques such as UV-Vis Spectroscopy and HPLC.
* Working knowledge of GMP, risk assessments, and laboratory waste management practices. · Proficiency in statistical analysis, with experience using tools such as Minitab and GraphPad Prism.
* Experience in the management and supervision of staff, providing guidance and support where appropriate.
* Serve as a subject matter expert in data generation, laboratory investigations, and scientific support during audits and inspections.
* Previous experience in a similar role within a regulated or scientific environment is highly desirable.
What is it like to work at Aerogen?
Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer:
* Excellent medical care.
* Bonus & Pension.
* ‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun.
* We pledge 1% of profits and time to charities and organisations
Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact
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