If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions -- join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Combination Products, Medical Device Development Engineer in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
You will plan and perform characterization of pre-filled syringe and other drug delivery devices to support program timelines according to project plans. You will have hands on development and qualification of device test methods, fixtures, and custom accessories (which may be electromechanical in nature). You will author technical reports and process descriptions as required, be an accomplished user of device testing instruments such as the ZebraSci silicone oil imager, INSTRON tensile test machine, Mitutoyo QVX302, Lansmont Transportation simulator, and other engineering tools.
You will develop process descriptions to standardize testing procedures across analysts, as well as assess and report data with a clear understanding of its reliability, interpret findings and draw authoritative conclusions and recommendations so that their significance can be appreciated. You will establish and maintain a close working relationship with suppliers, design consultants and contribute to oversite of external collaboration partners. Liaise effectively with internal departments (International Marketing, Regulatory Affairs, Product Development, Operations, QA, etc.) to ensure that the proposed design meets their requirements and expectations.
You will oversee the transfer of projects to Commercial Manufacturing/Operations Group, and ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/MDD/GMP/GLP, 21CRF820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards. Finally, you will keep the various process description documents up to date and contribute to the tech transfer documentation, present data at the team and Department meetings, and maintain and contribute to Quality Systems 21 CFR820.30 and ISO 13485 within the group to ensure consistency and conformance with GxP working practices.
* Medical Device Engineer I: Bachelor of Science with five to eight years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Masters of Science with three to six years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Ph.D. with one to three years of experience in the pharmaceutical, biotech, device or drug delivery industry
* Medical Device Engineer II: Bachelor of Science with nine to thirteen years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Masters of Science with seven to eleven years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Ph.D. with three to six years of experience in the pharmaceutical, biotech, device or drug delivery industry
* B.S. or M.S. degree in Mechanical/Electrical/Biomedical/Material/Chemical Engineering, Pharmaceutical Sciences, or related applicable technical field
* Understanding and experience of the principles and concepts within the area of device development in the pharmaceutical industry
* Knowledge of the drug development process and the importance of the application of device development capability to this process
* Basic knowledge and experience of other areas outside of own specialist area such as formulation and analytical development
* In-depth knowledge of relevant compliance systems and experienced in authoring relevant sections in regulatory submissions (IND, IMPD, BLA, MAA etc.)
* Experience with the development of devices for biotechnology compounds
* Good communication skills and strong interpersonal skills are essential
* Demonstrated leadership capabilities, organization, flexibility, and the ability to operate in a fast-paced environment
* Ability to demonstrate up to date technical knowledge
* Strong work habits and commitment to the position
* Problem solving, a hands-on scientific approach, innovation and creativity
* Ability to identify critical activities and prioritize tasks
Next Steps -- Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.