Senior Associate Scientist, QC Analytical

Gilead Sciences•Foster City, CA

About The Position

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.

Requirements

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.
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

Nice To Haves

Experience with following methods SEC, CEX, RP-HPLC, icIEF

Responsibilities

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.
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.