Associate Principal Scientist (Associate Director) - Regulatory Affairs - CMC, Biologics

The Associate Principal Scientist position is equivalent to an Associate Director position, responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises. Responsibilities include participation in the authorization process, completion of global regulatory assessments, and lead authoring of IND / CTAs, BLAs, or global post approval submissions.

Requirements

• B.S. in a science, engineering, or a related field (advanced degree preferred)
• 10 years of subject matter expertise in biologics CMC development or manufacturing
• Experience in biologics regulatory CMC in both pre-approval and registration
• Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance)
• Proven experience in critically reviewing detailed scientific information and assessing technical arguments
• Demonstrated superior oral and written communication skills in multicultural settings
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
• Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days