Candidate Role: In this highly visible role we are looking for a candidate with strong experience in designing and managing advanced analytical projects, particularly in the area of biologic drug development. Primary responsibilities include analytic program design integrated with later-stage regulatory strategy, and related project management to timelines, milestones and deliverables to plan. Further required is the ability to identify, communicate and implement advanced LC-MS based analytic approaches and related method validation strategies that can be applied into later-stage biologic development and regulatory packages. The candidate will also be able to build highly successful relationships with scientific and senior-level team members both within BioAnalytix and with leading pharmaceutical partners and customers. The candidate should have a strong technical background in biopharmaceutical development plus advanced LC-MS based analytical systems and methods, as well as proven experience and strong skills in data analysis, report writing, and project presentation. Regulatory knowledge, SOP and LIMS driven workflows and experience in GMP-level therapeutic development within a pharmaceutical company is a plus.
• Design, manage and deliver advanced analytic programs in biologic drug development with leading pharmaceutical customers worldwide
• Manage internal research and partnered projects to plan; identify key areas of opportunity and risk; communicate, plan and implement solutions that enable thought-leading results
• Prepare, review and present project progress, results, analysis and strategic recommendations both internally and externally
• Design, develop and implement advanced analytic workflows and related SOP’s
• Manage the design and transfer of validated methods into partner/customer laboratories
• Serve as project lead with pharmaceutical partners and customers in both a scientific and a business management capacity