Assoc Director, Device Engineering

New Today

Overview At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description The Device Engineering team at Gilead is seeking a qualified Associate Director of Device Engineering to drive commercial readiness and manage the life cycle of drug-device combination products. This individual will be responsible for leading cross functional teams to establish new manufacturing sites and commercialize new products. Expertise in design controls, process development, new product introduction, design transfer, and process validation is essential. Job Responsibilities Lead cross-functional team to complete design transfer to internal and external manufacturing sites – including executing process characterization studies, selecting and specifying manufacturing equipment, and authoring/reviewing design control documents. Lead product and / or process improvement projects. Lead quality and business process improvement projects. Mentor junior engineers. Manage technical issues with legacy device components of combination products to ensure supply chain continuity. Provide technical support for manufacturing site selection activities. Implement harmonized risk management for legacy products per ISO 14971. Qualifications Basic Qualifications: Doctorate and 5+ years of relevant experience OR Master’s and 8+ years of relevant experience OR Bachelor’s and 10+ years of relevant experience OR Preferred Qualifications: Expertise running multifunctional teams and managing technical issues at contract manufacturing organizations. Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements. Expertise working with equipment vendors and manufacturers including creating RFPs, developing user requirements, and qualifying equipment. Experience with design, execution, and statistical analysis of process characterization studies. Execution of root cause analysis, deviation management, and investigation. Strong verbal, written, and interpersonal communication skills are required. Must be able to write clear, concise, and error-free documents. Compensation and Benefits The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Equal Employment Opportunity For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or 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 ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the \'Know Your Rights\' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT; YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. 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 apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0047660 Full Time/Part Time Full-Time Job Level Associate Director Click below to return to the Gilead Careers site
#J-18808-Ljbffr
Location:
Foster City, CA, United States
Job Type:
PartTime

We found some similar jobs based on your search