Senior Associate, Manufacturing
Core
Support Production Leadership in continuous improvement, operational planning, and technical writing to drive safe, compliant, and efficient manufacturing operations for biological drugs.
Role type
Senior Associate, Manufacturing Operations
Builds
Production instructions, operational schedules, and technical documentation for scheduled campaigns
Domain
Biopharmaceutical manufacturing (cell culture, purification, GMP)
Required skills
Operational planning, technical writing, changeover management, problem analysis, data trend evaluation, GMP compliance, regulatory filings, equipment validation, team coordination, technical training
Preferred skills
Media and buffer preparation, cell culture expertise, purification knowledge, scheduling proficiency, safety systems knowledge
Technologies
GMP systems, validation tools, scheduling software
Responsibilities
Support Production Leadership in continuous improvement and operational planning; Transfer methods into Production instructions; Schedule work tasks to support project timelines; Draft and manage broad scope technical documents; Direct changeover activities; Track ongoing problems and develop solutions; Evaluate data for trends impacting systems; Provide technical direction and training to less senior personnel; Coordinate daily operational activities across a unit
Seniority
Senior, hands-on IC with mentorship responsibilities
