Associate Director, Device Development
Qualified candidates will focus on the development of parenteral combination products (e.g., autoinjectors, needle safety devices, reconstitution kits, etc.) by overseeing a team of engineers who lead device project teams. We are seeking a motivated, detail oriented individual able to contribute in a cross-functional team setting.Specific Job Responsibilities
Knowledge & Skills
- Lead team of engineers responsible for the development of drug delivery devices from initial concept generation through commercialization.
- Oversee development and execution of technical evaluation plans and ensure compliance with design control procedures.
- Author, review, and approve technical reports and design control documentation.
- Author, review, and approve regulatory filing content related to combination products (IND, NDA, etc.).
- Oversee technology transfer of combination product manufacturing to clinical and commercial manufacturing sites.
- Support device product quality investigations, CAPAs, and change control activities.
- Effectively communicate ideas, project goals, and results to team members across functions and departments.
- Qualified candidates should be self-motivated and organized, knowledgeable of relevant scientific literature, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions.
Required Education & Experience
- Strong verbal, written, and interpersonal communication skills.
- Able to write clear, concise, and error-free documents.
- Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.
- A Bachelor's Degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or a related scientific field and a minimum of ten (10) years of relevant industry OR a Master's Degree and a minimum of eight (8) years of relevant industry.
- Experience with the development and commercialization of combination products.
- Working knowledge of FDA, EMA, and cGMP standards for combination products.
- Experience leading combination product development projects and managing device engineers.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_CgAbout Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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