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For Current Gilead Employees and Contractors:Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.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 DescriptionThe incumbent is responsible for analytical support of Gilead commercial products . Accountabilities cover small molecule drug substance and drug product including release, stability, investigations, change control and analytical method life cycle management as detailed below:
Represent Global Quality Control in the CMC team for assigned commercial products as an analytical operations lead (AOL), provide analytical support for drug substance and drug product, release and stability, manage life cycle of commercial products, such as, product line extension, shelf-life/retest period, revision of procedure and specification
Accountable to oversee a variety of studies, trend stability data, prepare, review and approve necessary reports. Provide scientifically sound and data-based support of product investigations, impact assessments, and other change controls
Work with internal and contract organizations to conduct laboratory investigations as needed to ensure investigations are closed in a timely and compliant manner
Provide support to fulfill regulatory commitments and to address regulatory related inquiries for commercial products, including updated stability summary reports for annual report and other required documentation
Support routine commercial manufacturing related activities including review and approve release data, participate in audits as needed, and provide support for inspection needs at Gilead and contract sites as required
Essential Duties and Job Functions:
Effective communication with both external contract partner and internal cross-functional teams to meet Gilead business objectives
Ability to clearly define objectives and bring issues to timely resolution
Work with Regulatory & Quality Assurance to ensure that all applicable FDA regulations are followed and properly documented
Responsible for managing assigned products; well experienced with Empower, LIMS, change control as well as other documentation systems
Manage and evaluate laboratory deviation and investigation incidences and determine need for escalation
Prioritize projects and determine resource constraints as needed
Perform investigations as required to support commercial products
Serve as the technical and operational resource for the stability related activities
Interface with other PDM functions on project strategy
Apply current Good Manufacturing Processes (cGMPs) and Good Laboratory Practices (GLPs) concepts daily
Review test data and results to ensure compliance with appropriate specifications and protocols
Lead or participate in group meetings, present data, and prepare information for others to present
Ability to use statistically based software to perform data trend analysis and assist in investigations.
Use Microsoft Office software applications to write, revise, and execute protocols, methods, specifications, Standard Operating Procedures (SOPs), and reports
Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills
Knowledge, Experience & Skills
Past experience in quality control and analytical development, working with CMOs and testing labs, method development/validation, QC/stability support, conducting investigation, trouble shooting, and regulatory CMC support is preferred
Minimum Qualifications:
8+ years of experience with BA or BS degree in chemistry or Biology OR
6 + years of experience with MS degree in chemistry or Biology OR
0 + years of experience with PhD degree in chemistry or Biology
The salary range for this position is: $154,020.00 - $199,320.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.For additional benefits information, visit:https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 ApplicantAccommodations@gilead.com for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.