Principal Scientist

Role Summary

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 glycosylation methods and biological function understanding
• Mentor and guide scientists in their roles
• Set clear expectations and prioritize work packages
• Recruit and hire new talent
• Accountable for defining glycosylation methods and control strategy across the late-phase biologics portfolio and building deep understanding of how this relates to biological function
• Drive proactive and continuous improvement of glycosylation control strategies and functional understanding
• Serve as the business process owner for comparability packages from Pivotal to Commercial
• Support the design/justification/execution of end-to-end control strategy development through a proactive definition of the product quality targets
• Deliver 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 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

Qualifications

• Ph.D. with 8+ years or M.S. with 10+ years in Analytical Chemistry or related fields of industrial experience in biologics analytical development and/or structural characterization with people leader accountabilities
• Significant expertise in mass spectrometry and higher order structure techniques commonly used for biologics structural characterization
• Experience with technologies may include but not limited to Liquid Chromatography with Fluorescence or Mass Spectrometry, HILIC chromatography, Total sialic acid (TSA), SEC, IEX, CGE
• Subject matter expert in establishing comprehensive control strategies for biologics products
• Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product
• Proven track record in drafting regulatory documentation at all stages, including IND, BLA, and PAS filings
• Demonstrated ability of building strong collaborations with other CMC functions
• Strong business acumen, with ability to balance resource, budget, and program milestones
• Working knowledge of lab automation, computer validation, data governance, data science, knowledge management and data protection
• Leadership qualities including collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence

Skills

• Analytical development leadership
• Glycosylation methods and functional understanding
• Regulatory writing and filings (IND, BLA, PAS)
• Cross-functional collaboration and program management
• Mass spectrometry and higher order structure techniques

Education

• Ph.D. or M.S. in Analytical Chemistry or related field