AstraZeneca Pharmaceuticals LP Associate Scientist II/ Scientist I - BPD in Gaithersburg, Maryland
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.
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.
The successful candidate will be able to lead a cross functional combination product development teams and/or be a senior scientific contributor to complex technical development and problem solving. The candidate should be able to conduct the design, development and implementation of new drug delivery devices. The candidate will work with her/his team to ensure that device design, component selection, manufacturability and testing meet the product needs. This person will regularly interface with staff and leaders in Device Development, Quality, Regulatory Affairs, and across biologics product development. He/She should be capable of presenting at senior management meetings, health authority meetings and audits. He/she will be able to lead technical development with external development partners and component suppliers. In addition he/she will drive problem solving activities using state of the art tool such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design.
Major Duties and Responsibilities (including supervising others):
Lead or be a strong technical contributor to a cross functional team in the selection, development, scale up and commercialization of drug delivery devices for the MedImmune pipeline
Be a senior scientific contributor to complex problem solving and technical development
Contribute to departmental combination product development capability by applying and maintaining a high level of knowledge and expertise
Influence and educate cross-functional stakeholders and leaders on device development and commercialization best practices
Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborations
Drive a Quality mindset and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (e.g. risk management, Design Controls, ISO standards etc.)
Contribute to regulatory filings
Ability to develop and implement best practices / business processes
Engineering degrees or equivalent
The right candidate will have 5+ years’ experience in combination product development. Years of required experience will vary based on the highest level of education completed, the level of expertise within combination products and the level of position being interviewed for.
Other Skills and Qualifications:
In addition, the candidate should have excellent leadership skills to lead a cross functional team and ensure success of the project. Experience in working with external companies is also highly desirable. A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is a must. Excellent communication skills are required.
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.