Senior Device Engineer II
Senior Device Engineer II
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Senior Device Engineer II
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., autoinjectors, 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 cross-functional teams responsible for the development of drug delivery devices from initial concept generation through commercialization.
- Develop and execute technical evaluation plans, conduct experiments on-site, and supervise experiments performed at contract sites.
- Author technical reports and design control documentation.
- Contribute to regulatory filing content related to combination products (IND, NDA, etc.).
- Lead 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.
Skills & 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.
Required Education & Experience
- A Bachelor's Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field and a minimum of eight (8) 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 six (6) years of relevant industry experience, OR a PhD Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field and a minimum of two (2) years of relevant industry experience.
- Experience with the development and commercialization of combination products.
- Working knowledge of FDA and cGMP standards for combination products.
Preferred Education & Experience
- Experience leading combination product development projects.
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
About 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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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