Senior Device Engineer II (Combination Products)

Senior Device Engineer II (Combination Products)
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 (Combination Products)

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 devices and drug-device combination products such as pre-filled syringes and auto-injectors. We are seeking a motivated, detail oriented individual with cross-functional leadership experience.

Specific Job Responsibilities

• Deliver technical leadership in the area of device development, identifying solutions to meet stakeholder needs, partnering with suppliers and contract manufacturing organizations (CMOs), and driving product development.
• Lead device project teams in developing complex drug delivery devices from early phase through commercialization.
• Create and maintain design control documentation throughout a drug delivery device product lifecycle.
• Participate in new formulation evaluation and optimization related to drug delivery devices. Develop and execute technical evaluation plans, conducting experiments on-site and supervising experiments performed at contract sites.
• Establish device assembly manufacturing processes and lead technology transfer of manufacturing to clinical and commercial manufacturing sites.
• Lead technical aspects of device product quality investigations.
• Author regulatory content pertinent to drug delivery devices.
• 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.
• Position may include managing one or more device engineers.

Knowledge & Skills:

• Strong verbal, written, and interpersonal communication skills.
• 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.
• Required Education & Experience
• A Bachelor's Degree in chemical engineering, mechanical engineering, biomedical engineering, or a related scientific field and a minimum of eight (8) years of relevant industry experience with device development, OR a Master's Degree and a minimum of six (6) years of experience, OR a Ph.D and a minimum of two (2) years of experience.
• Experience with development and commercialization of drug delivery devices.
• Experience with medical device design control and quality system regulations (QSRs).
• Working knowledge of the FDA, cGMP, and GCP standards, as well as regulatory guidance documents such as Annex 13.
  

Preferred Experience

• Experience with primary container systems.
• Experience in cross-functional team leadership.
• Experience working with drug product/medical device contract manufacturing organizations (CMOs).

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 commercialises 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.


For jobs in the United States:
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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Sr-Device-Engineer-II_R0016250





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