California Jobs
Principal Scientist, Analytical Ops
California Jobs, San Mateo, California, United States, 94409
Overview
Principal Scientist, Biologics Analytical Development (Pivotal and Commercial) - United States, California, Foster City. The role leads analytical development activities including analytical project leadership and development of analytical methods, ensuring product quality targets and specifications are established for pivotal development projects with robust patient-centric considerations, and supporting regulatory filing strategies. Position: Principal Scientist in Biologics Analytical Development (Pivotal and Commercial). 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 Develop analytical control strategies for drug substance and drug product, ensuring patient-centric considerations are incorporated Develop 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 the adoption of novel and state-of-the-art analytical technologies and approaches Manage and mentor talent to cultivate a world-class Biologics AD organization Basic Qualifications
Bachelor's Degree and Ten Years' Experience Masters' Degree and Eight Years' Experience PhD and Five Years' Experience 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 include collaboration, building and developing high-performing teams, accountability, cross-functional engagement and influence, and program management. Ability to build high-performing teams and to set clear and measurable goals for staff and prioritize projects and resources 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
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Principal Scientist, Biologics Analytical Development (Pivotal and Commercial) - United States, California, Foster City. The role leads analytical development activities including analytical project leadership and development of analytical methods, ensuring product quality targets and specifications are established for pivotal development projects with robust patient-centric considerations, and supporting regulatory filing strategies. Position: Principal Scientist in Biologics Analytical Development (Pivotal and Commercial). 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 Develop analytical control strategies for drug substance and drug product, ensuring patient-centric considerations are incorporated Develop 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 the adoption of novel and state-of-the-art analytical technologies and approaches Manage and mentor talent to cultivate a world-class Biologics AD organization Basic Qualifications
Bachelor's Degree and Ten Years' Experience Masters' Degree and Eight Years' Experience PhD and Five Years' Experience 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 include collaboration, building and developing high-performing teams, accountability, cross-functional engagement and influence, and program management. Ability to build high-performing teams and to set clear and measurable goals for staff and prioritize projects and resources 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
#J-18808-Ljbffr