Process Development Senior Principal Scientist
Core
Lead commercial formulation and fill/finish process development for late-stage biologics, with a specific focus on Antibody-Drug Conjugates (ADCs), integrating data to guide product design and ensure manufacturability.
Role type
Senior Principal Scientist (Process Development & Formulation)
Builds
Stable, high-quality biologics drug products (including ADCs) for commercialization and life cycle management.
Domain
Biotechnology / Pharmaceutical Manufacturing (ADCs, Biologics)
Deliverable
production ML models | product features
Required skills
ADC drug product formulation, liquid and lyophilized formulation development, sterile filling, technology transfer to CMOs/CDMOs, predictive modeling with AI/ML, regulatory strategy authoring, statistical design of experiments, analytical biophysics (UPLC/HPLC, SEC, IEX, etc.), programming (Python, R, SQL), data visualization (Tableau, Spotfire, D3js), statistical software (SAS, JMP, Minitab).
Preferred skills
Advanced degree in Engineering/Pharmaceutics/Biotechnology, 8+ years in pharma/biotech, direct ADC linker-payload stability and degradation pathway expertise, global multi-functional team leadership.
Responsibilities
Lead planning and execution of lab studies for drug product design and tech transfer; develop and characterize formulations for biologics; lead internal/external technology transfer and troubleshoot manufacturing campaigns; apply AI/ML for predictive modeling and workflow acceleration; manage a matrixed team of engineers and scientists; author regulatory submissions and responses to regulatory questions.
Seniority
Principal, hands-on IC with team leadership
