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 an Associate Director/Director - Device Development 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
Be part of Medimmune team to oversee device development for combination products involving parenteral devices with biologics and peptides, identify cutting edge device technologies for novel product including platform development. This position will lead device development activities for the portfolio and require significant interaction with cross functional teams within Medimmune, as well as collaborating with AstraZeneca's manufacturing, regulatory, and quality organizations. This individual must be able to effectively work in a matrix environment and should have leadership qualities in leading and mentoring junior staff. Product development experience in the areas of injection pen devices, Auto injectors, and large volume wearable patches will be highly desired. Experience with both early stage and late stage device development in these areas is a must. This individual will be responsible for preparing submission document to various agencies, -- in particular injection based systems for parenteral administration.
This person will work closely with both internal stakeholders and external partners (design firm, device partners) and cross functional areas (business and commercial, and external suppliers and consultants). The incumbent is charged to lead strategy for device development and related aspects of programs. The selected person will be expected to achieve project targets in a timely fashion and to quality standards. A key attribute for the successful candidate should be the ability to lead and influence/motivate scientists, and stake holders in cross functional groups and build collaborative teams
- Take responsibility for the design and development aspects of new device development projects and be proactive in proposing new ideas and solving problems.
- Develop strategy for novel device development through partners/CMOs/device development partners
- Establish and maintain a close working relationship with suppliers and design consultants and contribute to management of external collaborations.
- Work effectively with internal departments (commercial, Regulatory Affairs, formulation, quality, Operations, etc.) to ensure that the proposed design meets their requirements and expectations.
- Development experience in at least one of the combination products such as wearable devices, pen injectors, or auto injector is a must
- Work with QA regarding DHF, development of SOPs, design review verification and validation for devices (external and internal collaboration)
- Experience with device validation and PPQs
- Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/MDD/GMP/GLP and safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards. Prepare formal reports and contributions to regulatory documentation.
- Provide guidance to fellow team members and contribute to the training and development of less experienced personnel by acting as coach/mentor as appropriate.
- Experience with primary container closure systems
- PhD in Chemical Engineering, Biomedical Engineering, Mechanical Engineering or Materials Science, or equivalent required with 11-13 years of experience
- MS in Biochemistry, Chemistry, or equivalent required with 13-15 years of experience
- PhD in Chemical Engineering, Biomedical Engineering, Mechanical Engineering or Materials Science or equivalent required with 8 - 11 years of experience
- MS in Biochemistry, Chemistry, or equivalent required with 11+ years of experience
- Has strong technical competence and credibility in the field of device development and is able to give assured technical direction.
- Good communication skills, strong interpersonal skills are essential, demonstrated leadership capabilities, organization, flexibility and the ability to operate in a fast paced environment are an integral part of this position.
- Problem solving and innovation are also fundamental qualities for this role.
- An in depth understanding and experience of the principles and concepts within the area of device development in the pharmaceutical industry, and is expected to demonstrate up to date technical knowledge.
- A basic knowledge and experience of other areas outside of own specialist area such as formulation and analytical development.
- An in-depth knowledge of relevant compliance systems and experienced in authoring relevant sections in regulatory submissions (IND, BLA, MAA etc.).
- Work experience in insulin devices or GLP1s is an advantage
- Experience and demonstrated launches of combination products for biotechnology compounds would be a distinct advantage.
- Experience with Project management, grant chart creation, FDA interactions
- Working experience with device components
- Experience with product launch, complaint investigation, root cause analysis
- Experience in drafting response to agency
- Demonstrated experience in leading and managing scientists that are either direct reports or in a matrix scenario including mentoring and career development.
- Background knowledge in the areas of drug delivery is desirable (such as microneedles and implantable technologies)
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.