The Associate Principal Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises
Job Summary
The Associate Principal Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises.
Responsibilities include the preparation and submission of CMC sections for commercial or new biologics products, and providing mentoring and coaching to Sr. Scientist / Scientist.
The salary range for this role is $142,400.00 - $224,100.00, with eligibility for annual bonus and long-term incentive, plus a comprehensive benefits package.
Matching Summary
The Associate Principal Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises.
Salary
Base: $142,400.00 - $224,100.00; Bonus/Equity: Annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
Biologics CMC development or manufacturing
Biologics regulatory CMC
Authoring agency interactions
Global CMC guidelines
IND/BLA submission authoring
Nice-to-have
Creative problem solving
Flexibility in responding to priorities
Superior oral and written communication
Innovative solutions to complex problems
Experience with ADCs
Key Requirements
10 years subject matter expertise
B.S. in science, engineering, or related field
Biologics IND, License Application (BLA) and/or post approval filing experience