Senior Associate Scientist, Analytical Operations

About Gilead

At Gilead, we e creating a healthier world for all people. For more than 35 years, we have 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 in Analytical Operations at Gilead, you are part of the Biologics Analytical Development (Pivotal and Commercial) department.

We seek a candidate with strong expertise in compendial, protein content and impurity methods for biologics. The candidate will be encouraged to take advantage of career growth opportunities, including developing new technical skills.

This position will located at Gilead corporate HQ in Foster City, CA.

Key Responsibilities:

• General knowledge of overall drug development process relevant to pharmaceutical and/or biotech organizations.
• A good understanding of method development (compendial, ELISA and/or other assays) for early and late stage biotherapeutics is required.
• The successful candidate will be expected to demonstrate hands-on experimental responsibilities in the laboratory, independently champion technology development projects, be involved in new assay evaluation and optimization, and proactively seek out senior personnel to optimize the workflow.
• The candidate will contribute to the development of compendial methods, ELISA, qPCR, or other analytical assays under general supervision, participating in assay development work. The candidate will also participate in other analytical support and compatibility studies, as required.
• Support hands-on development and analyze in-process samples, drug substances, and drug products using techniques such as HPLC, UV-Vis, SoloVPE, water content, osmolality, visual appearance, turbidity, and pH.
• Lead internal and external laboratory investigations using compendial methods (USP, Ph. Eur., JP).
• Review development and QC analytical data supporting manufacturing generated through manual and instrumental techniques.
• Advise project teams on global requirements and collaborate with QC for product-specific verification and troubleshooting.
• Troubleshoot instrumentation and testing anomalies, provide training to qualify analysts in testing and data review, and drive continuous improvement initiatives to enhance quality and laboratory processes.
• Support development and analyze in-process samples, drug substances, and drug products using techniques such as ELISA, qPCR, and other analytical plate based assays.
• Develop, optimize and execute laboratory techniques such as ELISA, DNA and other plate-based assays commonly used for biologics to support analytics and non-routine activities to deliver project goals.
• Operates scientific equipment, selects appropriate methods and techniques to perform experiments, and prepare related reports. Plan and organize details of experiments with guidance.
• Reviews testing data and results to ensure compliance to appropriate test methods, specifications, and protocols.
• Authors, revises and reviews analytical methods, specifications, protocols, reports, and other documentation for development.
• The applicant should be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments. Ability to proactively identify issues and develop solutions in a collaborative multidisciplinary environment. This is a highly collaborative environment where willingness and ability to communicate and work effectively with individuals across various project teams is essential.
• Candidates should be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking, proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
• The applicant is also expected to exercise considerable latitude in determining objectives and approaches to assignments, and should be an effective communicator of ideas, project goals, and results to team members across cross-functional roles/departments.

Knowledge, Experience, and Skills:

• Good communication skills (both verbal and technical) and interpersonal skills are required. Must be able to work in highly flexible and effective teams.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Demonstrates ability to recognize anomalous and inconsistent results and interpret experimental outcomes.
• Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy.

Required:

• Bachelors in Chemistry/ Biochemistry with at least 5+ years of compendial, protein content and impurity method experience required OR
• Masters in Chemistry/ Biochemistry with at least 3+ years of compendial, protein content and impurity method experience required

Preferred:

• Preferred experience includes a working knowledge and proficiency with analytical techniques, such as appearance (color, clarity, visible particles), pH, turbidity, water content, spectroscopy/absorbance assays (SoloVPE, UV-Vis), chromatographic separations (HPLC/UPLC), and physiochemical methods (osmolality), ELISA assays (residual host cell protein, protein A), and residual DNA (qPCR).
• Knowledge of GMP, GLP or GxP is highly preferred

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.