Principal Scientist in Biologics Analytical Development (Pivotal and Commercial)

* Mentor and guide scientists in their roles.* Set clear expectations and prioritize work packages.* Recruit and hire new talent.* Defining excipient and process reagent testing and control strategy across the late-phase biologics portfolio and building deep understanding of how this relates to product stability.* Driving continuous improvement of excipient strategies.* Support the design/justification/execution of end-to-end control strategy development through a proactive definition of the product quality targets.* Delivering high quality work packages for supporting Pivotal INDa and marketing applications.* Serve as an analytical project lead (ASTL) for late-phase program overseeing all analytical deliverables.* Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies.* Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful commercialization of the late-stage Biologics portfolio.* Act as a key member of the extended Analytical Development leadership team to shape late-stage development strategies* Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standard, comparability, and specifications.* Drive for the adoption of novel and state-of-the-art characterization technologies and approaches.* Recruit, hire, and mentor talent to help cultivate a world class Biologics AD organization.* Responsible for conducting scientific research for the development of drug candidates or the research support of marketed drugs.* Applies the principles and techniques of Analytical Chemistry to products and problems.* Works in collaboration with more senior scientists or scientific directors to advance the development of state-of-the-art techniques to characterize substances, assays and tools.* Works on moderately complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.* Advises Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.* Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.* Maintains full working knowledge of state-of-the art principles and theories, applying such knowledge to the direction that supports Company interests.* Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and strategy.* Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills. #J-18808-Ljbffr