Senior Associate Scientist, QC Analytical

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.