Director, Process Development (Pivotal & Commercial)
Core
Define and execute purification development strategy for a portfolio of pivotal, commercial, and lifecycle-management biologics programs, providing scientific direction for process development, characterization, scale-up, and commercial manufacturing support.
Role type
Director, Process Development (Pivotal & Commercial)
Builds
Robust and manufacturable drug substance purification processes for biologics
Domain
Biopharmaceuticals / Downstream Processing
Required skills
biologics purification process development, process characterization, scale-up, technology transfer, process control strategies, cGMP manufacturing, regulatory submissions, lifecycle management, team leadership, cross-functional stakeholder management
Preferred skills
people leadership, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, regulatory inspections, process performance qualification, continued process verification, comparability assessments, viral clearance, quality risk management, design of experiments, process modeling, automation
Technologies
chromatography, virus inactivation, virus filtration, ultrafiltration/diafiltration, high-throughput experimentation, process modeling
Responsibilities
Define and execute purification development strategy; Provide scientific and technical direction for process development and scale-up; Oversee development of robust drug substance purification processes; Direct risk-based process characterization and control strategies; Provide technical support for technology transfers; Partner with Manufacturing Sciences and Technology for engineering runs and validation; Provide technical leadership for regulatory content and inspection support; Identify and communicate technical risks to stakeholders; Lead, coach, and develop a high-performing team of scientists and engineers
Seniority
Director, strategic leadership with hands-on technical direction
