Director of Analytical Sciences

Organization
BioAnalytix
Job Location
Cambridge, MA
Salary
Benefits
Job Description

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.

Key Responsibilities:

• 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

Requirements

Qualifications:

• PhD in LC-MS based analytical chemistry, with a minimum 5+ years of analytics in biologic development in a leading pharmaceutical company or regulatory consulting organization
• Proven ability to deliver projects to objectives and timelines while managing internal teams and external customer and partner programs, people 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 including IND and BLA filings in biologic development

About Our Organization

BioAnalytix is a pharmaceutically oriented spin-out from the Barnett Institute of Chemical and Biological Analysis at Northeastern University in Boston, MA. Founded by thought leaders in biologic drug development, regulatory strategy, and advanced analytics, BioAnalytix works with leading pharmaceutical companies to develop and apply advanced analytic methods and data in enabling, improving and accelerating biologic therapeutics from development through market.

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