Technical Director, Device Engineer

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Qualified candidates will focus on the development of parenteral combination products (e.g., auto-injectors, needle safety devices, reconstitution kits, etc.) lead device project teams, and serve as subject matter expert for commercial combination products. We are seeking a driven, motivated and detail oriented individual able to lead in a cross-functional team setting.

Specific Job Responsibilities

· Lead technical development of drug delivery devices from initial concept generation through commercialization.

· Oversee development and execution of technical evaluation plans and execution of experiments on-site as well as at contract sites.

· Contribute to 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 & Skills

· A Bachelor’s Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field and a minimum of twelve (12) years of relevant industry experience, OR a Master’s Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field and a minimum of ten (10) years of relevant industry experience, OR a PhD Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field and a minimum of eight (8) years of relevant industry experience.

· Experience with the development and commercialization of combination products.

· Experience leading combination product development projects is desired.

· Strong verbal, written, and interpersonal communication skills are required.

· Must be able to write clear, concise, and error-free documents.

· Must be able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.

· Working knowledge of FDA and cGMP standards for combination products.

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.avature.net/Gilead