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Job Description
Company Overview: BioAnalytix is a pharmaceutically oriented spin-out from the Barnett Institute of Chemical and Biological Analysis at Northeastern University in Boston, MA. Founded in 2012 by thought leaders in biologic drug development, regulatory strategy, and advanced analytics, BioAnalytix works with leading pharmaceutical companies to develop and apply advanced analytic technologies, methods and data in enabling, improving and accelerating biologic therapeutics from development through market. Candidate Role: In this highly visible role we are looking for a candidate with direct experience and expertise in designing, managing and delivering advanced analytical projects and CMC packages in biologic drug development. Primary responsibilities include analytic/biologic 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 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 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, as well as strong skills and proven experience in data analysis, report writing, and project presentation. Direct regulatory experience in GMP-level biologic drug development within a pharmaceutical company is a plus.Requirements
Key Responsibilities: • Design, manage and deliver advanced analytic programs in late-stage biologic drug development and regulatory filings with leading pharmaceutical customers and partners worldwide • Manage partnered projects to plan; identify key areas of opportunity and risk; communicate, plan and implement solutions that enable highly successful results • Present advanced analytical data and related regulatory strategies in key scientific, regulatory and biologic development program meetings • Manage executive level relationships with strategic partners at the highest level of excellence • Serve as project lead with pharmaceutical partners and customers in both a scientific and a business management capacity Qualifications: • PhD in analytic or biochemistry with a minimum 5+ years of protein analytic, protein process sciences and/or regulatory experience in biologic drug development in a leading pharmaceutical company or regulatory organization • Proven ability to deliver projects to objectives and timelines while managing internal and external teams, partnered programs and relationships at the highest levels of excellence • Highly detail-oriented, self-motivated and results driven • Excellent interpersonal, presentation, communication and writing skills • Knowledge of later-stage regulatory processes particularly including IND and BLA filingsRequeriments :
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