Associate Director, R&D AstraZenecaLocation: Gaithersburg, Maryland, United States
Job reference: R-015437
Posted date: Nov. 03, 2017
This important and strategic position within MedImmune is for the role of a Device Development Associate Director / Director that will lead development of device technologies/platforms and lead combination product programs. The incumbent will be responsible for specific device areas (e.g. auto-injectors, primary containers, wearable injectors), leading combination product development activities including technology assessments, device selection, design controls, design and development, scale-up and launch. The position also includes leadership of or mentorship of team leads accountable for combination product development and commercialization. The incumbent will work cross-functionally with both internal staff and leaders in Biopharmaceutical Development (e.g. formulation, drug product process development, etc.), Quality, Regulatory, business/marketing, Operations), and with CMC Teams, Product Development Teams (PDTs) and Global Product Teams (GPTs). The incumbent will also be accountable for oversight of development activities undertaken by external partners (design and development firms, device company partners). A key attribute for the successful candidate should be the ability to lead technical staff, collaborate, increase technical capabilities, and influence cross-functional leaders and stakeholders.
Expectations for this role include the following:
- Management of direct reports (engineers and/or scientists), including providing technical and leadership guidance and mentorship
- Oversight of development of device platforms for the portfolio and/or leadership of a combination product program for the MedImmune pipeline
- Contribute to building the 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
- Liaise effectively and influence product teams
- 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.)
- Review regulatory filings and contribute to strategies regarding health authority interactions
- Ability to develop and implement best practices / business processes
- Contribute to and provide leadership for the development of strategies for devices (platform and project)
- Extensive understanding and expertise with primary container closure systems (e.g. prefilled syringes, cartridges) including functional testing, material properties, component manufacturing processes and control strategies. Experience with prefilled syringe / cartridge manufacturers
- Extensive understand and expertise with parenteral drug delivery systems (e.g. auto-injectors, wearable injectors, inhalation devices or other systems). Experience working with drug delivery device companies.
- Extensive knowledge of the combination product development process. Experience with late stage development and launch support is desired.
- In-depth knowledge and experience with global health authority requirements, current expectations and relevant standards.
EDUCATION AND EXPERIENCE REQUIREMENTS
Director: B.S., M.S. or PhD in engineering, life sciences or equivalent with 13+ years of experience
Associate Director: B.S., M.S. or PhD in engineering, life sciences or equivalent with 11+ years of experience
Experience in development of drug delivery devices or combination products is required
Next Steps – Apply today!
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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.