Under general supervision of an Executive Director/Senior Director, the Principal Scientist /Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies.
Lead the preparation and submission of CMC sections for commercial or new biologics products.
Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and cross-functional teams.
Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change documentation.

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.
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
Must be proficient in English; additional language skills are a plus.
B.S. in a biological science, engineering, or a related field (advanced degree preferred).

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

Principal Scientist – Regulatory Affairs-CMC

Key skills