Principal Scientist / Senior Scientist - Device Development - BPD
The candidate will be a part of MedImmune drug delivery and device development group responsible for combination product development involving parenteral injection devices delivering biologics, peptides and synthetic molecules. This position is part of the device development team and will lead the development and implementation of state-of-the-art technologies to develop injection devices and provide expert advice for a diverse and complex pipeline of drug assets through entire portfolio ranging from clinical to commercial launch.
This role will lead technical and cross functional teams to ensure successful development and launch of drug/device combination products. The Senior Device Engineer will lead a cross-functional combination product team to develop detailed engineering specifications, create device designs, oversee design verification/validation, and support regulatory submissions of combination products. This position will report to the Director of Combination Products Development.
This position requires significant interactions with biopharmaceutical development functions particularly working with project teams in formulation sciences, process engineering, device quality and regulatory, as well as collaborating with AstraZeneca's manufacturing sites and external device development partners. This individual must be independent and demonstrate the leadership and business acumen to work in a matrix environment effectively.
Major Duties and Responsibilities:
Leads combination product project teams as a technical team lead, fully responsible for all the device deliverables to support combination product development
- To provide expertise in patient-centric methodologies to understand targeted therapeutic populations’ profile, conduct market research and support human factors studies to collect user needs and identify unmet requirements
- To create design concepts and generate creative device features to best meet user requirements;
- To establish technical solutions for complex problems requiring ingenuity and creativity; make practical device development plan to ensure timely delivering of device deliverables
- To oversee engineering tests for design verification and HF studies for validation
- To create industrialization strategies and apply extensive expertise as a specialist in process development and process validation for high volume injection molding of plastic parts, sub-assembling and final assembling of combination products
Leads the combination product team by utilizing a forward-looking perspective to contribute to “go/no go” decisions for new combination product introductions.
Applies critical thinking to solve complex issues while multi-tasking in a fast-pace working environment. Strong matrix management skills needed to fulfill multi-functional collaborations with both internal and external partners in device development and manufacturing.
Internally recognized as an expert by the AstraZeneca device cross functional group through internal presentations and critical contributions to device development by championing best practice technologies, device component tooling, automation, validation and change management.
Education and Experience:
Degree in mechanical engineering, biomedical engineering, materials science or related engineering fields. Post-graduate degrees in the related engineering fields is an asset.
Senior Scientist: Bachelors degree and 15+ years of experience, Masters and 13+ years of experience, or Ph.D. and 5+ years of experience of device development/manufacturing experience in medical device or pharmaceutical industry.
Principal Scientist: Bachelors degree and 17+ years of experience, Masters and 15+ years of experience, or Ph.D. and 8+ years of experience of device development/manufacturing experience in medical device or pharmaceutical industry.
Product development experience in the area of biologics delivery and devices including auto injectors, pre-filled syringe, pen injectors and/or large volume bolus injectors is preferred. Proven experience in launching of combination product through the entire development cycle in a CMC environment is highly desired.
Excellent written and verbal communication skills are required.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.