Principal Scientist in Biologics Analytical Development

Principal Scientist in Biologics Analytical Development (Pivotal and Commercial) United States - California - Foster City Process/Product Development & Operations Regular We are seeking a talented and highly motivated Principal Scientist for our Pivotal and Commercial Biologics Characterization team in Biologics Pivotal and Commercial Analytical Development. Broad experience in analytical development from early development to commercial launch, filing experience with FDA/EMA, and in-depth technology understanding for biological products are the key in this role. A solid understanding of GMPs and CMC requirements is expected. Responsibilities Provide leadership to a group of scientists focused on excipient / process reagent methods and product understanding. 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. Specific Education 3+ years of experience and PhD in Chemistry.ORBS or MS degree with extensive industry experience. Specific Job Responsibilities 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. 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. Excellent verbal communication skills and interpersonal skills are required. #J-18808-Ljbffr