Platform Lead-Device Development (Senior Scientist/Principal Scientist) Location MD, Gaithersburg - Corporate Headquarters Job Description Platform Lead-Device Development (Senior Scientist/Principal Scientist) This important and strategic position within MedImmune/Astra Zeneca is for the challenging role of a Device Development lead that will integrate design and development aspects of new combination drug /devices programs. By working closely with both internal and external partners and cross functional areas (business and commercial, and external suppliers and consultants) the incumbent is charged to lead device development and related aspects of programs from technology assessments and selection through development to commercial scale up and launch. 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 scientists and stake holders in cross functional groups. Expectations for this role include the ability to: - Apply knowledge and expertise in the area of combination product development to support the achievement of project targets. Develop and maintain a level of knowledge and competence, perhaps extending to specialist expertise in a specific area of Device Development. - Take responsibility for the design and development aspects of new device development projects and be proactive in proposing new ideas and solving problems. - 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. - Establish and maintain a close working relationship with suppliers and design consultants and contribute to management of external collaborations. Liaise effectively with internal departments (commercial, Regulatory Affairs, Development, Operations, etc.) to ensure that the proposed design meets their requirements and expectations. - Working experience in autoinjector, patch pumps, other wearable injector is a must - Work with QA regarding DHF, development of SoPs, design review verification and validation for devices (external and internal collaboration) - Oversee the transfer of projects to operations for Commercial Manufacturing. - 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. - Working knowledge in connected health technologies, device connectivity to Apps/software etc. - Experience with primary container closure systems ~BSP Position Requirements Basic Qualifications: Education/Experience Senior Scientist
PhD with 5 years in Mechanical Engineering, BioMedical, Materials Science or a related discipline MS with 7 years in Mechanical Engineering, BioMedical, Materials Science or a related discipline BS with 10 years in Mechanical Engineering, BioMedical, Materials Science or a related discipline Principal Scientist PhD with 8 years in Mechanical Engineering, BioMedical, Materials Science or a related discipline MS with 10 years in Mechanical Engineering, BioMedical, Materials Science or a related discipline BS with 15 years in Mechanical Engineering, BioMedical, Materials Science or a related discipline Posiiton Qualifications: 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. Extensive knowledge of the drug development process and the application of sound device development processes and techniques. 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.). Experience and demonstrated launches of combination products for biotechnology compounds would be a distinct advantage. A key attribute for the successful candidate should be the ability to lead and influence scientists and stake holders in cross functional groups Experience with Project management, grant chart creation, FDA interactions Working experience with device components *LI-MEDIPRI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation
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