Principal Scientist – Regulatory Affairs, CMC

Role Overview

• Responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies
• Leading the preparation and submission of CMC sections for commercial or new biologics products
• Provide CMC Regulatory leadership within Regulatory and on cross-functional teams
• Develop and execute detailed global regulatory submissions
• Collaborate with partner groups to ensure compliance, scientific excellence, accuracy, and completeness of submissions
• Resolve complex project issues through collaboration and provide recommendations to Regulatory CMC leadership team as appropriate.

Requirements

• B.S. in a biological science, engineering, or a related field (advanced degree preferred)
• At least ten years of relevant experience including biologics or vaccine Regulatory CMC, or development; manufacturing, testing, or licensure of biological products; or closely related fields.
• Strong listening skills.
• The candidate must be proficient in English; additional language skills are a plus.
• The candidate may be required to travel on a periodic basis.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days