Principal Scientist – Analytical Ops

Principal Scientist – Analytical Ops

Requirements

• Bachelor’s Degree and Ten Years’ Experience
• Masters’ Degree and Eight Years’ Experience
• PhD and Five Years’ Experience
• Extensive experience with analytical method development and control strategies of biologics products
• Well versed in separation techniques (e.g. UHPLC, CE-SDS, iCIEF, CEX) commonly used for biologics analytical development
• Subject matter expert in establishing comprehensive control strategies for biologics products
• Expertise in the development/qualification of various assays, including for purity and process related impurities
• 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

Responsibilities

• Provide leadership to a group of analytical development scientists
• Mentor and guide scientists in their roles
• Set clear expectations and prioritization of work packages
• Manage workload and resources effectively
• Developing analytical control strategies for drug substance and drug product, ensuring patient-centric considerations are incorporated
• Development of robust analytical methods for drug substance and drug product appropriate for pivotal and commercial programs
• Design and execution of scientifically sound and regulatory compliant method bridging strategies
• 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
• Exhibit comprehensive knowledge of cGMP practices and requirements
• 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 analytical technologies and approaches
• Manage and mentor talent to help cultivate a world class Biologics AD organization

Preferred Qualifications

• Ph.D. with 5+ years or M.S. with 9+ years or B.S. with a minimum of 11+ years in Analytical Chemistry or related fields of industrial experience in biologics analytical development
• Extensive experience with analytical method development and control strategies of biologics products
• Well versed in separation techniques (e.g. UHPLC, CE-SDS, iCIEF, CEX) commonly used for biologics analytical development
• Subject matter expert in establishing comprehensive control strategies for biologics products
• Expertise in the development/qualification of various assays, including for purity and process related impurities
• 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
• Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.