Senior Associate Scientist, Analytical Operations

Gilead Sciences•Foster City, CA

9d•Onsite

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 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 be located at Gilead corporate HQ in Foster City, CA.

Requirements

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
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.

Nice To Haves

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

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.