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
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Associate Scientist, QC Analytical at Gilead you will be vital to the success of Clinical Biologics QC. This role provides support of daily operations. You will support cross-functional teams, embrace continuous improvement, and ensure timely project completion and regulatory compliance.
Overview:
Supporting outsourced testing coordination, sample management and shipping, and data entry from internal labs/CTLs/CMOs into Gilead’s LIMS.
Managing the release/stability testing and data review supporting Gilead’s Clinical biologics drug substances and drug products.
Support method robustness/validation/transfer and troubleshooting activities (protocols, reports) including laboratory work.
Experience with following methods SEC, CEX, RP-HPLC, icIEF
Facilitate and manage change controls, deviations, and investigations.
Contribute to refining QC procedures across Gilead’s biologics manufacturing network, ensuring compliance with global cGMP and Gilead’s Quality Management System.
Qualifications:
Experience in biologics Quality Control with knowledge of industry best practices and trends.
Understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
Be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories independently and with support depending on task.
Be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness with guidance.
Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
Demonstrated the ability to influence processes and outcomes across functions.
Required:
5+ years of experience with a BA / BS degree in Chemistry or Biology OR
3+ years of experience with MS degree in Chemistry or Biology
Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
Strong organizational and planning skills.
Shows excellent verbal and written communication skills and collaborative interpersonal skills.
Knowledge and experience in Biologics quality control
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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.
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 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' poster.