Senior Associate Scientist, Analytical Operations

About the role

The Senior Associate Scientist in Analytical Operations at Gilead is 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.

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.
• Independently champion technology development projects, be involved in new assay evaluation and optimization, and proactively seek out senior personnel to optimize the workflow.
• Contribute to the development of compendial methods, ELISA, qPCR, or other analytical assays under general supervision, participating in assay development work.
• 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.
• Develop, optimize and execute laboratory techniques such as ELISA, qPCR, and other analytical plate based assays.
• Operate scientific equipment, select 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.

Requirements

• 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.

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 hold them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Pay and Benefits

The salary range for this position is: $126,820.00 - $164,120.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For Additional Benefits Information, Visit here.