Associate Director, Device Development
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
- 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.
Knowledge & Skills
- 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 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_Cg
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.
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 email@example.com 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.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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.